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市場調查報告書

醫療設備的藥事申請 (RA) 管理業務受託市場 2019年∼2030年

Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030

出版商 ROOTS ANALYSIS 商品編碼 917172
出版日期 內容資訊 英文 551 Pages
商品交期: 最快1-2個工作天內
價格
醫療設備的藥事申請 (RA) 管理業務受託市場 2019年∼2030年 Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030
出版日期: 2019年11月30日內容資訊: 英文 551 Pages
簡介

本報告提供聚焦醫療設備的藥事申請 (RA) 管理的業務受託服務供應商的目前形勢的相關調查,醫療設備藥事申請 (RA) 外包市場檢討,醫療設備供應鏈的各階段的藥事申請 (RA)的作用相關討論,醫療設備的法規、醫療費償付形勢,主要企業的簡介,基準分析,及市場預測等。

第1章 序論

第2章 摘要整理

第3章 簡介

  • 本章概要
  • 醫藥品臨床研究委外機構 (CRO)
  • 醫療設備產業上CRO所扮演的角色
  • 醫療設備CRO的種類
  • CRO所提供的服務的種類
  • 醫療設備的藥事申請 (RA) 相關業務外包需求
  • 在選定恰當的CRO合作夥伴時的主要討論事項
  • 與CRO協同合作的優點
  • 跟CRO的協同合作相關風險與課題
  • 結論

第4章 醫療設備供應鏈的藥事申請 (RA)的作用

  • 本章概要
  • 醫療設備供應鏈概要
  • 醫療設備供應鏈的影響要素
  • 醫療設備供應鏈管理的KPI
  • 醫療設備供應鏈的藥事申請 (RA)的最佳化

第5章 醫療設備的法規、醫療費償付形勢

  • 本章概要
  • 醫療設備的一般法規、醫療費報銷指南
  • 北美法規、醫療費償付形勢
  • 歐洲的法規、醫療費償付形勢
  • 亞太地區、其他 (RoW) 的法規、醫療費償付形勢
  • 地區的法規環境比較
  • 結論

第6章 競爭情形

  • 本章概要
  • 提供醫療設備藥事申請 (RA) 相關服務的CRO:企業清單
  • 結論

第7章 企業簡介

  • 本章概要
  • 在北美設置本部的CRO
    • CTI Clinical Trial and Consulting (CTI)
    • Medpace
    • NAMSA
    • PAREXEL
    • Premier Research
    • Underwriters Laboratory (UL)
  • 在歐洲設置本部的CRO
    • CROMSOURCE
    • ICON
    • PharmaLex
    • SteriPack
  • 在亞太地區、其他 (RoW) 地區設置本部的CRO
    • MIC Medical

第8章 基準分析

第9章 藥事申請外包模式的指南

第10章 醫療設備開發企業和CRO的關係:主要的促進因素、KPI

第11章 市場預測

  • 本章概要
  • 預測手法、前提條件
  • 整體醫療設備藥事申請 (RA) 外包市場
  • 醫療設備藥事申請 (RA) 外包市場:各地區的分佈
  • 醫療設備藥事申請 (RA) 外包市場:各RA相關服務形式的分佈
  • 醫療設備藥事申請 (RA) 外包市場:各設備等級的分佈
  • 醫療設備藥事申請 (RA) 外包市場:各治療領域的分佈
  • 醫療設備藥事申請 (RA) 外包市場:RA相關服務、各地區的分佈
  • 醫療設備藥事申請 (RA) 外包市場:各設備等級、地區的分佈
  • 醫療設備藥事申請 (RA) 外包市場:治療領域、各地區的分佈

第12章 結論

第13章 考察

第14章 重要考察

第15章 附錄I:圖表資料

第16章 附錄II:企業、組織的清單

目錄

Overview:

According to the World Bank, more than 50,000 different types of medical devices are currently being used on a daily basis in healthcare facilities across the globe. In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion. It is also worth noting that, since January 2018, the USFDA approved over 130 medical devices. However, a relatively large proportion of developers lack the resources and technical expertise required to handle regulatory filings and effectively manage the processes associated with procuring marketing authorizations from regional regulators. Moreover, keeping up with evolving regulatory guidelines, rising costs of legal advice and increasing effort required for preparing of technical documentation, is difficult for companies with limited finances. In addition, establishing reimbursement strategies for medium to high-risk devices is also a complicated process and innovator companies usually do not have the expertise to deal with payers and insurance providers. According to a recent report, 68% of medical device companies reports prepared and submitted by in-house players are either rejected or were reported to have multiple major gaps in their clinical evaluation report (CER) and supporting evidences by the notified bodies. In fact. in a survey published in the 2016 edition of Global Medical Device Supply Chain, regulatory requirements were highlighted among the primary areas of concern within the medical device value chain. Furthermore, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments.

“Presently, several medical devices are being investigated in clinical trials for variety of indications across the globe that are likely to get market approval in near future. In order to facilitate the approval in different geographies, there seems to be enhanced business opportunities for companies offering required services in this domain.” - Business Development Manager, a Hungary based Mid-sized company.

The aforementioned challenges have led many medical device developers, especially the smaller players and certain established companies as well, to outsource parts of their regulatory operations to capable contract research organizations (CROs). Generally, CROs are known to offer a number of benefits, which include cost benefits, reductions in time-to-market and, in this specific case, an in-depth and up-to date regulatory support. Given that the global demand for medical devices is increasing at a substantial pace, the opportunity for CROs with expertise in regulatory affairs management is also on the rise. In the foreseen future, the growing complexity of regulatory processes across various developing and developed geographies is likely to prompt more developers to outsource various aspects of their dealings with regulatory authorities. Moreover, in order to cope up with latest changes in medical device-related regulations, several legacy CROs are re-evaluating their operational models and business strategies. Owing to the anticipated rise in demand for such services, the contract regulatory services domain is likely to witness the entry of a number of new players in the foreseen future.

Scope of the Report:

The ‘Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030' report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:

  • A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services, and popular therapeutic area(s).
  • A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).
  • An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
  • Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific). Each profile features a brief overview of the company, including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.
  • A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
  • An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
  • An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
  • A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device regulatory affairs outsourcing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management service offered (legal representation, project registration and clinical trial application, regulatory writing and publishing and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of the medical device regulatory affairs outsourcing CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order of company name):

  • Tania Persson, Business Development Manager, A+ Science
  • Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO
  • Troy Mccall, Chief Operating Officer, CROMSOURCE
  • Christian Wolflehner, Managing Director, Clinical Trial Specialist, CW Research & Management
  • Antal Solyom, Director, Medical Device Unit, HungaroTrial
  • Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research
  • C Omprakash, Technical Director and Partner, Vyomus Consulting

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Chapter Outlines:

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the medical device regulatory affairs management CROs market and its likely evolution in the short-midterm and long term.

Chapter 3 is a general overview of the various types of CROs that offer services to the medical devices industry. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in this domain. Further, it elaborates on the need for outsourcing in this domain, along with the various partnership models that have been adopted by CROs and medical device developers. In addition, the chapter highlights key points that developer companies need to consider for selecting a suitable contract research services provider for regulatory management services. It also features a detailed list of regulatory management services offered by contemporary CROs, along with a discussion on the various challenges within the market.

Chapter 4 includes a detailed discussion on the need of regulatory review / oversight across different stages of the medical device supply chain. It also emphasizes on the various factors that are likely to impact the performance of the medical device supply chain, along with strategies that are likely to assist in improving visibility in the supply chain. Subsequently, the chapter provides information on optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).

Chapter 5 features a discussion on the various guidelines established by major regulatory bodies for medical device approvals across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.

Chapter 6 provides a detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a comprehensive list of over 400 CROs engaged in this domain. In addition, it features an in-depth analysis of the market, based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap analysis, technical dossier set-up, vigilance & medical device report risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training), region(s) of operation wherein the company is offering regulatory management services, and popular therapeutic area(s).

Chapter 7 features detailed profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific), featuring a brief overview of the company including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.

Chapter 8 presents a benchmark analysis of the various players engaged in this domain. It highlights the focus areas of small-sized, mid-sized and large companies in terms of their expertise in medical device services. The analysis allows companies to compare their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.

Chapter 9 features an elaborate discussion on the various outsourcing business models adopted for regulatory affairs management in this domain, along with an informative Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.

Chapter 10 features an analysis on the key performance indicators used by sponsor companies to evaluate service providers that are active in this domain, based on information gathered via secondary research (for top-ten medical device players), as well as credible inputs from primary research.

Chapter 11 presents a likely evolution of the market in the short to mid-term and long term (2019-2030). In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management services offered (legal representation, project registration and clinical trial application, regulatory writing and publishing and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 12 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the medical device regulatory affairs outsourcing market, based on the research and analysis described in the previous chapters.

Chapter 13 presents insights from the survey conducted for this study. We invited over 300 stakeholders that provide regulatory affairs management services to medical device developers / manufacturers. The participants, who were primarily CXO level / senior management representatives of their respective companies, helped us develop a deeper understanding on the nature of their services, prevalent trends and associated commercial potential of this domain.

Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of company names) Tania Persson (Business Development Manager, A+ Science), Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO), Troy Mccall (Chief Operating Officer, CROMSOURCE), Christian Wolflehner (Managing Director, Clinical Trial Specialist, CW Research & Management), Antal Solyom (Director, Medical Device Unit, HungaroTrial), Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research), and C Omprakash (Technical Director and Partner, Vyomus Consulting).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in this report.

TABLE OF CONTENTS

1 PREFACE

  • 1.1. Scope of the Report
  • 1.2. Research Methodology
  • 1.3. Chapter Outlines

2 EXECUTIVE SUMMARY

3 INTRODUCTION

  • 3.1. Chapter Overview
  • 3.2. Contract Research Organizations (CROs)
    • 3.2.1. Evolution of CROs
  • 3.3. Role of CROs in the Medical Device Industry
  • 3.4. Types of Medical Device CROs
  • 3.5. Types of Services Offered by CROs
    • 3.5.1. Types of Regulatory Affairs-Related Services Offered by CROs
  • 3.6. Need for Outsourcing Regulatory Affairs-Related Operations for Medical Devices
  • 3.7. Key Considerations for Selecting a Suitable CRO Partner
  • 3.8. Advantages of Working with CROs
  • 3.9. Risks and Challenges Related to Working with CROs
  • 3.10. Concluding Remarks

4 ROLE OF REGULATORY AFFAIRS IN MEDICAL DEVICE SUPPLY CHAIN

  • 4.1. Chapter Overview
  • 4.2. Overview of Medical Device Supply Chain
    • 4.2.1. Importance of Regulatory Affairs in Medical Device Supply Chain
      • 4.2.1.1. Concept and Feasibility Assessment Stage
      • 4.2.1.2. Preclinical Stage
      • 4.2.1.3. Manufacturing / Production Stage
      • 4.2.1.4. Marketing Stage
      • 4.2.1.5. Post-Marketing Stage
  • 4.3. Factors Affecting the Medical Device Supply Chain
  • 4.4. Key Performance Indicators for Medical Device Supply Chain Management
  • 4.5. Optimization of Regulatory Affairs in the Medical Device Supply Chain
    • 4.5.1. Digitalization of the Medical Device Supply Chain

5 REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES

  • 5.1. Chapter Overview
  • 5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
  • 5.3. Regulatory and Reimbursement Landscape in North America
    • 5.3.1. The US Scenario
      • 5.3.1.1. Regulatory Authority
      • 5.3.1.2. Review / Approval Process
      • 5.3.1.3. Reimbursement Landscape
        • 5.3.1.3.1. Payer Mix
        • 5.3.1.3.2. Reimbursement Process
    • 5.3.2. The Canadian Scenario
      • 5.3.2.1. Regulatory Authority
      • 5.3.2.2. Review / Approval Process
      • 5.3.2.3. Reimbursement Landscape
        • 5.3.2.3.1. Payer Mix
        • 5.3.2.3.2. Reimbursement Process
    • 5.3.3. The Mexican Scenario
      • 5.3.3.1. Regulatory Authority
      • 5.3.3.2. Review / Approval Process
      • 5.3.3.3. Reimbursement Landscape
        • 5.3.3.3.1. Payer Mix
  • 5.4. Regulatory and Reimbursement Landscape in Europe
    • 5.4.1. Overall Scenario
      • 5.4.1.1. Overall Regulatory Authority
      • 5.4.1.2. Overall Review / Approval Process
    • 5.4.2. The UK Scenario
      • 5.4.2.1. Regulatory Authority
      • 5.4.2.2. Review / Approval Process
      • 5.4.2.3. Reimbursement Landscape
        • 5.4.2.3.1. Payer Mix
        • 5.4.2.3.2. Reimbursement Process
    • 5.4.3. The French Scenario
      • 5.4.3.1. Regulatory Authority
      • 5.4.3.2. Review / Approval Process
      • 5.4.3.3. Reimbursement Landscape
        • 5.4.3.3.1. Payer Mix
        • 5.4.3.3.2. Reimbursement Process
    • 5.4.4. The German Scenario
      • 5.4.4.1. Regulatory Authority
      • 5.4.4.2. Review / Approval Process
      • 5.4.4.3. Reimbursement Landscape
        • 5.4.4.3.1. Payer Mix
        • 5.4.4.3.2. Reimbursement Process
    • 5.4.5. The Italian Scenario
      • 5.4.5.1. Regulatory Authority
      • 5.4.5.2. Review / Approval Process
      • 5.4.5.3. Reimbursement Landscape
        • 5.4.5.3.1. Payer Mix
        • 5.4.5.3.2. Reimbursement Process
    • 5.4.6. The Spanish Scenario
      • 5.4.6.1. Regulatory Authority
      • 5.4.6.2. Review / Approval Process
      • 5.4.6.3. Reimbursement Landscape
        • 5.4.6.3.1. Payer Mix
        • 5.4.6.3.2. Reimbursement Process
  • 5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
    • 5.5.1. The Australian Scenario
      • 5.5.1.1. Regulatory Authority
      • 5.5.1.2. Review / Approval Process
      • 5.5.1.3. Reimbursement Landscape
        • 5.5.1.3.1. Payer Mix
        • 5.5.1.3.2. Reimbursement Process
    • 5.5.2. The Brazilian Scenario
      • 5.5.2.1. Regulatory Authority
      • 5.5.2.2. Review / Approval Process
      • 5.5.2.3. Reimbursement Landscape
        • 5.5.2.3.1. Payer Mix
        • 5.5.2.3.2. Reimbursement Process
    • 5.5.3. The Chinese Scenario
      • 5.5.3.1. Regulatory Authority
      • 5.5.3.2. Review / Approval Process
      • 5.5.3.3. Reimbursement Landscape
        • 5.5.3.3.1. Payer Mix
        • 5.5.3.3.2. Reimbursement Process
    • 5.5.4. The Indian Scenario
      • 5.5.4.1. Regulatory Authority
      • 5.5.4.2. Review / Approval Process
      • 5.5.4.3. Reimbursement Landscape
        • 5.5.4.3.1. Payer Mix
    • 5.5.5. The Israeli Scenario
      • 5.5.5.1. Regulatory Authority
      • 5.5.5.2. Review / Approval Process
      • 5.5.5.3. Reimbursement Landscape
        • 5.5.5.3.1. Payer Mix
    • 5.5.6. The Japanese Scenario
      • 5.5.6.1. Regulatory Authority
      • 5.5.6.2. Review / Approval Process
      • 5.5.6.3. Reimbursement Landscape
        • 5.5.6.3.1. Payer Mix
        • 5.5.6.3.2. Reimbursement Process
    • 5.5.7. The New Zealand Scenario
      • 5.5.7.1. Regulatory Authority
      • 5.5.7.2. Review / Approval Process
      • 5.5.7.3. Reimbursement Landscape
        • 5.5.7.3.1. Payer Mix
        • 5.5.7.3.2. Reimbursement Process
    • 5.5.8. The Singaporean Scenario
      • 5.5.8.1. Regulatory Authority
      • 5.5.8.2. Review / Approval Process
      • 5.5.8.3. Reimbursement Landscape
        • 5.5.8.3.1. Payer Mix
        • 5.5.8.3.2. Reimbursement Process
    • 5.5.9. The South Korea Scenario
      • 5.5.9.1. Regulatory Authority
      • 5.5.9.2. Review / Approval Process
      • 5.5.9.3. Reimbursement Landscape
        • 5.5.9.3.1. Payer Mix
        • 5.5.9.3.2. Reimbursement Process
    • 5.5.10. The South African Scenario
      • 5.5.10.1. Regulatory Authority
      • 5.5.10.2. Review / Approval Process
      • 5.5.10.3. Reimbursement Landscape
    • 5.5.11. The Taiwanese Scenario
      • 5.5.11.1. Regulatory Authority
      • 5.5.11.2. Review / Approval Process
      • 5.5.11.3. Reimbursement Landscape
        • 5.5.11.3.1. Payer Mix
        • 5.5.11.3.2. Reimbursement Process
    • 5.5.12. The Thailand Scenario
      • 5.5.12.1. Regulatory Authority
      • 5.5.12.2. Review / Approval Process
      • 5.5.12.3. Reimbursement Landscape
  • 5.6. Comparison of Regional Regulatory Environment
  • 5.7. Concluding Remarks

6 COMPETITIVE LANDSCAPE

  • 6.1. Chapter Overview
  • 6.2. CROs Offering Regulatory Affairs-Related Services for Medical Devices: List of Companies
    • 6.2.1. Analysis by Year of Establishment
    • 6.2.2. Analysis by Size of Employee Base
    • 6.2.3. Analysis by Location of Headquarters
    • 6.2.4. Analysis by Area of Specialization
    • 6.2.5. Analysis by Type of Regulatory Affairs-Related Service Offered
    • 6.2.6. Analysis by Type of Additional Services Offered
    • 6.2.7. Analysis by Device Class
    • 6.2.8. Analysis by Type of Clientele
    • 6.2.9. Analysis by Medical Device Regulatory Compliance Authorities
    • 6.2.10. Analysis by Region of Operation
    • 6.2.11. Analysis by Popular Therapeutic Areas
  • 6.3. Concluding Remarks

7 COMPANY PROFILES

  • 7.1. Chapter Overview
  • 7.2. CROs Headquartered in North America
    • 7.2.1. CTI Clinical Trial and Consulting (CTI)
      • 7.2.1.1. Company Overview
      • 7.2.1.2. Service Portfolio
      • 7.2.1.3. Future Outlook
    • 7.2.2. Medpace
      • 7.2.2.1. Company Overview
      • 7.2.2.2. Financial Information
      • 7.2.2.3. Service Portfolio
      • 7.2.2.4. Future Outlook
    • 7.2.3. NAMSA
      • 7.2.3.1. Company Overview
      • 7.2.3.2. Service Portfolio
      • 7.2.3.3. Future Outlook
    • 7.2.4. PAREXEL
      • 7.2.4.1. Company Overview
      • 7.2.4.2. Service Portfolio
      • 7.2.4.3. Future Outlook
    • 7.2.5. Premier Research
      • 7.2.5.1. Company Overview
      • 7.2.5.2. Service Portfolio
      • 7.2.5.3. Future Outlook
    • 7.2.6. Underwriters Laboratory (UL)
      • 7.2.6.1. Company Overview
      • 7.2.6.2. Service Portfolio
      • 7.2.6.3. Future Outlook
  • 7.3. CROs Headquartered in Europe
    • 7.3.1. CROMSOURCE
      • 7.3.1.1. Company Overview
      • 7.3.1.2. Service Portfolio
      • 7.3.1.3 Future Outlook
    • 7.3.2. ICON
      • 7.3.2.1. Company Overview
      • 7.3.2.2. Financial Information
      • 7.3.2.3. Service Portfolio
      • 7.3.2.4 Future Outlook
    • 7.3.3. PharmaLex
      • 7.3.3.1. Company Overview
      • 7.3.3.2. Service Portfolio
      • 7.3.3.3 Future Outlook
    • 7.3.4. SteriPack
      • 7.3.4.1. Company Overview
      • 7.3.4.2. Service Portfolio
      • 7.3.4.3. Future Outlook
  • 7.4. CROs Headquartered in Asia-Pacific and Rest of the World
    • 7.4.1. MIC Medical
      • 7.4.1.1. Company Overview
      • 7.4.1.2. Service Portfolio

8 BENCHMARK ANALYSIS

  • 8.1. Chapter Overview
  • 8.2. Benchmark Analysis: Methodology
  • 8.3. Region-wise Benchmark Analysis
    • 8.3.1. North America, Peer Group I
    • 8.3.2. North America, Peer Group II
    • 8.3.3. North America, Peer Group III
    • 8.3.4. North America, Peer Group IV
    • 8.3.5. Europe, Peer Group V
    • 8.3.6. Europe, Peer Group VI
    • 8.3.7. Europe, Peer Group VII
    • 8.3.8. Europe, Peer Group VIII
    • 8.3.9. Asia Pacific and Rest of the World, Peer Group IX
    • 8.3.10. Asia Pacific and Rest of the World, Peer Group X
    • 8.3.11. Asia Pacific and Rest of the World, Peer Group XI
    • 8.3.12. Asia Pacific and Rest of the World, Peer Group XII
  • 8.4. Concluding Remarks

9 GUIDE TO REGULATORY OUTSOURCING MODELS

  • 9.1. Chapter Overview
  • 9.2. Guiding Models for Regulatory Outsourcing
    • 9.2.1. Functional Service Providers (FSP) Model: Large Medical Device Developers
      • 9.2.1.1. Vendor Evaluation
    • 9.2.2. End-to-End Model: Small-Sized Medical Device Developers
      • 9.2.2.1. Vendor Evaluation
    • 9.2.3. Hybrid Model: Mid-Sized Medical Device Developers
      • 9.2.3.1. Vendor Evaluation

10 MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS

  • 10.1. Chapter Overview
  • 10.2. Definition and Importance of Key Performance Indicators
  • 10.3. Key Considerations for Selection of Key Performance Indicators
  • 10.4. Types of Key Performance Indicators
    • 10.4.1. Financial Indicators
      • 10.4.1.1. Most Important KPIs
        • 10.4.1.1.1. Financial Stability
        • 10.4.1.1.2. Cost of Services Offered
        • 10.4.1.1.3. Comparative Analysis of Financial Indicators
      • 10.4.1.2. Industry Perspective
        • 10.4.1.2.1. Sponsor (Big Pharma) Perspective
        • 10.4.1.2.2. Contract Service Providers' Perspective
    • 10.4.2. Process / Capability Indicators
      • 10.4.2.1. Most Important KPIs
        • 10.4.2.1.1. Proximity to Sponsor
        • 10.4.2.1.2. Capability to Innovate / Mitigate Risk
        • 10.4.2.1.3. Strength of Service Portfolio
        • 10.4.2.1.4. Comparative Analysis of Process / Capability Indicators
      • 10.4.2.2. Industry Perspective
        • 10.4.2.2.1. Sponsor (Big Pharma) Perspective
        • 10.4.2.2.2. Contract Service Providers' Perspective
    • 10.4.3. Market Reputation Indicators
      • 10.4.3.1. Most Important KPIs
        • 10.4.3.1.1. Flexibility / Adaptability
        • 10.4.3.1.2. Time Management
        • 10.4.3.1.3. Quality / Reliability
        • 10.4.3.1.4. Regulatory Compliance / Track Record
        • 10.4.3.1.5. Comparative Analysis of Market Reputation Indicators
      • 10.4.3.2. Industry Perspective
        • 10.4.3.2.1. Sponsor (Big Pharma) Perspective
        • 10.4.3.2.2. Contract Service Providers' Perspective
  • 10.5. Comparison of Key Performance Indicators
  • 10.6. Concluding Remarks

11 MARKET FORECAST

  • 11.1 Chapter Overview
  • 11.2. Forecast Methodology and Key Assumptions
  • 11.3. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030
  • 11.4. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Geography, 2019 and 2030
    • 11.4.1. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030
      • 11.4.1.1. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030
      • 11.4.1.2. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030
    • 11.4.2. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030
      • 11.4.2.1. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030
      • 11.4.2.2. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030
      • 11.4.2.3. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030
      • 11.4.2.4. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030
      • 11.4.2.5. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030
      • 11.4.2.6. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030
    • 11.4.3. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030
      • 11.4.3.1. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030
      • 11.4.3.2. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030
      • 11.4.3.3. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030
      • 11.4.3.4. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030
    • 11.4.4. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030
  • 11.5. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service, 2019 and 2030
    • 11.5.1. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030
    • 11.5.2. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030
    • 11.5.3. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030
    • 11.5.4. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services, 2019-2030
    • 11.5.5. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030
    • 11.5.6. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030
    • 11.5.7. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030
    • 11.5.8. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030
    • 11.5.9. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030
  • 11.6. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030
    • 11.6.1. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030
    • 11.6.2. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030
    • 11.6.3. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030
  • 11.7. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030
    • 11.7.1. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030
    • 11.7.2. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System (CNS) Disorders, 2019-2030
    • 11.7.3. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030
    • 11.7.4. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030
    • 11.7.5. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030
    • 11.7.6. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030
    • 11.7.7. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2030
    • 11.7.8. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030
    • 11.7.9. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030
  • 11.8. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service and Geography
    • 11.8.1. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030
    • 11.8.2. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030
    • 11.8.3. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030
    • 11.8.4. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030
    • 11.8.5. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030
    • 11.8.6. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030
    • 11.8.7. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030
    • 11.8.8. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030
    • 11.8.9. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030
    • 11.8.10. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030
    • 11.8.11. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030
    • 11.8.12. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030
    • 11.8.13. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in North America, 2019-2030
    • 11.8.14. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Europe, 2019-2030
    • 11.8.15. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Asia-Pacific, 2019-2030
    • 11.8.16. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Rest of the World, 2019-2030
    • 11.8.17. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030
    • 11.8.18. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030
    • 11.8.19. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030
    • 11.8.20. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030
    • 11.8.21. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030
    • 11.8.22. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030
    • 11.8.23. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030
    • 11.8.24. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030
    • 11.8.25. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030
    • 11.8.26. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030
    • 11.8.27. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030
    • 11.8.28. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030
    • 11.8.29. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030
    • 11.8.30. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030
    • 11.8.31. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030
    • 11.8.32. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030
    • 11.8.33. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030
    • 11.8.34. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030
    • 11.8.35. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030
    • 11.8.36. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030
  • 11.9. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class and Geography
    • 11.9.1. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030
    • 11.9.2. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030
    • 11.9.3. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030
    • 11.9.4. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030
    • 11.9.5. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030
    • 11.9.6. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030
    • 11.9.7. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030
    • 11.9.8. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030
    • 11.9.9. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030
    • 11.9.10. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030
    • 11.9.11. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030
    • 11.9.12. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030
  • 11.10. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area and Geography
    • 11.10.1. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030
    • 11.10.2. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030
    • 11.10.3. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030
    • 11.10.4. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030
    • 11.10.5. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030
    • 11.10.6. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030
    • 11.10.7. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030
    • 11.10.8. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030
    • 11.10.9. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030
    • 11.10.10. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030
    • 11.10.11. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030
    • 11.10.12. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030
    • 11.10.13. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030
    • 11.10.14. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030
    • 11.10.15. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030
    • 11.10.16. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030
    • 11.10.17. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030
    • 11.10.18. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030
    • 11.10.19. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030
    • 11.10.20. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030
    • 11.10.21. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030
    • 11.10.22. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030
    • 11.10.23. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030
    • 11.10.24. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030
    • 11.10.25. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030
    • 11.10.26. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030
    • 11.10.27. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030
    • 11.10.28. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030
    • 11.10.29. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030
    • 11.10.30. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030
    • 11.10.31. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030
    • 11.10.32. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030
    • 11.10.33. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030
    • 11.10.34. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030
    • 11.10.35. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030
    • 11.10.36. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030

12 CONCLUSION

  • 12.1. Chapter Overview
  • 12.2. Key Takeaways

13 SURVEY INSIGHTS

  • 13.1. Chapter Overview
  • 13.2. Company Specifics of Respondents
  • 13.3. Designation of Respondents
  • 13.4. Types of Regulatory Affairs-Related Services
  • 13.5. Analysis by Region of Operation
  • 13.6. Type and Size of Clientele
  • 13.7. Average Number of Projects
  • 13.8. Proportion of Clients Outsourcing Regulatory Affairs-Related Services
  • 13.9. Cost of Outsourcing Regulatory Affairs-Related Services
  • 13.10. Current and Future Market Opportunity

14 EXECUTIVE INSIGHTS

  • 14.1. Chapter Overview
  • 14.2. A+ Science
    • 14.2.1. Company Snapshot
    • 14.2.2. Interview Transcript: Tania Persson, Business Development Manager
  • 14.3. AtoZ-CRO
    • 14.3.1. Company Snapshot
    • 14.3.2. Interview Transcript: Alexa Foltin-Mertgen, Business Development Manager
  • 14.4. CROMSOURCE
    • 14.4.1. Company Snapshot
    • 14.4.2. Interview Transcript: Troy Mccall, Chief Operating Officer
  • 14.5. CW Research & Management
    • 14.5.1. Company Snapshot
    • 14.5.2. Interview Transcript: Christian Wolflehner, Managing Director, Clinical Trial Specialist
  • 14.6. HungaroTrial
    • 14.6.1 Company Snapshot
    • 14.6.2. Interview Transcript: Antal Solyom, Director of Medical Device Unit
  • 14.7. Metrics Research
    • 14.7.1 Company Snapshot
    • 14.7.2. Interview Transcript: Dr. Nazish Urooj, Senior Manager, Medical & Clinical Operations
  • 14.8. Vyomus Consulting
    • 14.8.1 Company Snapshot
    • 14.8.2. Interview Transcript: Dr. C Omprakash, Technical Director and Partner

15 APPENDIX I: TABULATED DATA

16 APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

List Of Figures

  • Figure 3.1. Medical Device Development Process
  • Figure 3.2. Types of Medical Device CROs
  • Figure 3.3. Services Offered by CROs
  • Figure 3.4. Key Challenges within the Medical Device Supply Chain
  • Figure 3.5. Risks / Challenges Associated with Regulatory Service CROs
  • Figure 4.1. Key Components of Medical Device Supply Chain
  • Figure 4.2. Key Technologies for Digitalization of Medical Device Supply Chain
  • Figure 4.3. Applications of Blockchain in Medical Device Supply Chain
  • Figure 5.1. Key Regulatory Authorities for Medical Devices
  • Figure 5.2. Medical Devices Review / Approval Process: US
  • Figure 5.3. Healthcare Insurance Coverage in the US: Distribution by Type of Coverage
  • Figure 5.4. Medical Devices National Coverage Determination Process: US
  • Figure 5.5. Medical Devices Review / Approval Process: Canada
  • Figure 5.6. Healthcare Insurance Coverage in Canada: Distribution by Type of Coverage
  • Figure 5.7. Medical Devices Review / Approval Process: Mexico
  • Figure 5.8. Regulatory Bodies in EU5 Countries
  • Figure 5.9. Steps involved in CE Marking Process
  • Figure 5.10. Medical Devices Review / Approval Process: Europe
  • Figure 5.11. Medical Devices Review / Approval Process: UK
  • Figure 5.12. Healthcare Insurance Coverage in the UK: Distribution by Type of Coverage
  • Figure 5.13. Medical Devices Reimbursement Process: UK
  • Figure 5.14. Healthcare Insurance Coverage in France: Distribution by Type of Coverage
  • Figure 5.15. Medical Devices Reimbursement Process: France
  • Figure 5.16. Healthcare Insurance Coverage in Germany: Distribution by Type of Coverage
  • Figure 5.17. Medical Devices Reimbursement Process for In-Patient Setting: Germany
  • Figure 5.18. Medical Devices Reimbursement Process for Out-Patient Care: Germany
  • Figure 5.19. Healthcare Insurance Coverage in Italy: Distribution by Type of Coverage
  • Figure 5.20. Medical Devices Reimbursement Process: Italy
  • Figure 5.21. Healthcare Insurance Coverage in Spain: Distribution by Type of Coverage
  • Figure 5.22. Medical Devices Reimbursement Process: Spain
  • Figure 5.23. Medical Devices Review / Approval Process: Australia
  • Figure 5.24. Healthcare Insurance Coverage in Australia: Percentage Distribution by Type of Coverage
  • Figure 5.25. Medical Devices Review / Approval Process: Brazil
  • Figure 5.26. Medical Devices Reimbursement Process: Brazil
  • Figure 5.27. Medical Devices Review / Approval Process: China
  • Figure 5.28. Healthcare Insurance Coverage in China: Percentage Distribution by Type of Coverage
  • Figure 5.29. Medical Devices Reimbursement Process: Shanghai
  • Figure 5.30. Medical Devices Review / Approval Process: India
  • Figure 5.31. Healthcare Insurance Coverage in Israel: Percentage Distribution by Type of Coverage
  • Figure 5.32. Medical Devices Review / Approval Process: Japan
  • Figure 5.33. Medical Devices Reimbursement Process: Japan
  • Figure 5.34. Healthcare Insurance Coverage in Japan: Percentage Distribution by Type of Coverage
  • Figure 5.35. New Medical Devices Reimbursement Process: Japan
  • Figure 5.36. Medical Devices Review / Approval Process: New Zealand
  • Figure 5.37. Healthcare Insurance Coverage in New Zealand: Percentage Distribution by Type of Coverage
  • Figure 5.38. Medical Devices Review / Approval Process: Singapore
  • Figure 5.39. Medical Devices Review / Approval Process: South Korea
  • Figure 5.40. Healthcare Insurance Coverage in South Korea: Percentage Distribution by Type of Coverage
  • Figure 5.41. Medical Devices Review / Approval Process: South Africa
  • Figure 5.42. Medical Devices Review / Approval Process: Taiwan
  • Figure 5.43. Healthcare Insurance Coverage in Taiwan: Percentage Distribution by Type of Coverage
  • Figure 5.44. Medical Devices Review / Approval Process: Thailand
  • Figure 5.45. Heat Map Analysis: Comparison of Regional Regulatory Control for Medical Devices
  • Figure 5.46. Regulatory Control for Medical Devices: Regional Analysis by Device Risk Category
  • Figure 6.1. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment
  • Figure 6.2. Medical Devices Regulatory Affairs CROs: Distribution by Company Size
  • Figure 6.3. Medical Devices Regulatory Affairs CROs: Distribution by Geography
  • Figure 6.4. Medical Devices Regulatory Affairs CROs: Distribution by Company Size and Geography
  • Figure 6.5. Medical Devices Regulatory Affairs CROs: Distribution by Type of Regulatory Affairs-Related Services Offered
  • Figure 6.6. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
  • Figure 6.7. Medical Devices Regulatory Affairs CROs: Distribution by Type of Additional Services Offered
  • Figure 6.8. Medical Devices Regulatory Affairs CROs: Distribution by Device Class
  • Figure 6.9. Medical Devices Regulatory Affairs CROs: Distribution by Type and Size of Clientele
  • Figure 6.10. Medical Devices Regulatory Affairs CROs: Distribution by Medical Device Regulatory Compliance Authorities
  • Figure 6.11. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Region-wise)
  • Figure 6.12. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Country-wise)
  • Figure 6.13. Medical Devices Regulatory Affairs CROs: Popular Therapeutic Areas
  • Figure 7.1. CTI: Service Portfolio
  • Figure 7.2. Medpace: Annual Revenues, 2014-2018 (USD Million)
  • Figure 7.3. Medpace: Service Portfolio
  • Figure 7.4. NAMSA: Service Portfolio
  • Figure 7.5. PAREXEL: Service Portfolio
  • Figure 7.6. PAREXEL: Annual Revenues, 2014-2017 (USD Million)
  • Figure 7.7. Premier Research: Service Portfolio
  • Figure 7.8. Underwriters Laboratory (UL): Service Portfolio
  • Figure 7.8. CROMSOURCE: Service Portfolio
  • Figure 7.9. ICON: Annual Revenues, 2014-H1 2019 (USD Million)
  • Figure 7.10. ICON: Service Portfolio
  • Figure 7.11. PharmaLex: Service Portfolio
  • Figure 7.12. SteriPack: Service Portfolio
  • Figure 7.13. MIC Medical: Service Portfolio
  • Figure 8.1. Benchmark Analysis: Distribution by Region and Size of Employee Base
  • Figure 8.2. Benchmark Analysis: North America, Peer Group I
  • Figure 8.3. Benchmark Analysis: North America, Peer Group II
  • Figure 8.4. Benchmark Analysis: North America, Peer Group III
  • Figure 8.5. Benchmark Analysis: North America, Peer Group IV
  • Figure 8.6. Benchmark Analysis: North America, Peer Group V
  • Figure 8.7. Benchmark Analysis: Europe, Peer Group VI
  • Figure 8.8. Benchmark Analysis: Europe, Peer Group VII
  • Figure 8.9. Benchmark Analysis: Europe, Peer Group VIII
  • Figure 8.10. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group IX
  • Figure 8.11. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group X
  • Figure 8.12. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XI
  • Figure 8.13. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XII
  • Figure 8.14. Benchmark Analysis: Comparison across Peer Groups
  • Figure 9.1. Key Characteristics of Next-Generation FSP Model
  • Figure 9.2. Vendor Evaluation in FSP Model
  • Figure 9.3. Key Characteristics of End-to-End Model
  • Figure 9.4. Key Characteristics of Hybrid Model
  • Figure 10.1. Key Attributes for Selection of Key Performance Indicators (KPIs)
  • Figure 10.2. Types of KPIs
  • Figure 10.3. Financial Indicators: Comparative Analysis of KPIs considered by Big Pharma Companies
  • Figure 10.4. Financial Indicators: Sponsor (Big Pharma) Perspective
  • Figure 10.5. Financial Indicators: Contract Service Providers' Perspective
  • Figure 10.6. Process / Capability Indicators: Comparative Analysis of KPIs of Big Pharma Companies
  • Figure 10.7. Process / Capability Indicators: Sponsor (Big Pharma) Perspective
  • Figure 10.8. Process / Capability Indicators: Contract Service Providers' Perspective
  • Figure 10.9. Market Reputation Indicators: Comparative Analysis of KPIs of Big Pharma Companies
  • Figure 10.10. Market Reputation Indicators: Sponsor (Big Pharma) Perspective
  • Figure 10.11. Market Reputation Indicators: Contract Service Providers' Perspective
  • Figure 10.12. Comparison of Key Factors for KPI Selection for Medical Devices
  • Figure 11.1. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030 (USD Million)
  • Figure11.2. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Geography, 2019 and 2030 (USD Million)
  • Figure 11.3. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030 (USD Million)
  • Figure 11.4. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030 (USD Million)
  • Figure 11.5. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030 (USD Million)
  • Figure 11.6. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030 (USD Million)
  • Figure 11.7. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030 (USD Million)
  • Figure 11.8. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030 (USD Million)
  • Figure 11.9. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030 (USD Million)
  • Figure 11.10. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030 (USD Million)
  • Figure 11.11. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030 (USD Million)
  • Figure 11.12. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030 (USD Million)
  • Figure 11.13. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.14. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030 (USD Million)
  • Figure 11.15. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030 (USD Million)
  • Figure 11.16. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030 (USD Million)
  • Figure 11.17. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.18. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.19. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service, 2019 and 2030 (USD Million)
  • Figure 11.20. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030 (USD Million)
  • Figure 11.21. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030 (USD Million)
  • Figure 11.22. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030 (USD Million)
  • Figure 11.23. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services, 2019-2030 (USD Million)
  • Figure 11.24. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030 (USD Million)
  • Figure 11.25. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030 (USD Million)
  • Figure 11.26. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030 (USD Million)
  • Figure 11.27. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030 (USD Million)
  • Figure 11.28. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030 (USD Million)
  • Figure 11.29. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030 (USD Million)
  • Figure 11.30. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030 (USD Million)
  • Figure 11.31. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030 (USD Million)
  • Figure 11.32. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030 (USD Million)
  • Figure 11.33. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030 (USD Million)
  • Figure 11.34. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030 (USD Million)
  • Figure 11.35. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders, 2019-2030 (USD Million)
  • Figure 11.36. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030 (USD Million)
  • Figure 11.37. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030 (USD Million)
  • Figure 11.38. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030 (USD Million)
  • Figure 11.39. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030 (USD Million)
  • Figure 11.40. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2030 (USD Million)
  • Figure 11.41. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030 (USD Million)
  • Figure 11.42. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030 (USD Million)
  • Figure 11.43. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030 (USD Million)
  • Figure 11.44. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030 (USD Million)
  • Figure 11.45. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.46. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.47. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030 (USD Million)
  • Figure 11.48. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030 (USD Million)
  • Figure 11.49. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.50. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.51. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030 (USD Million)
  • Figure 11.52. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030 (USD Million)
  • Figure 11.53. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.54. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.55. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in North America, 2019-2030 (USD Million)
  • Figure 11.56. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Europe, 2019-2030 (USD Million)
  • Figure 11.57. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.58. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.59. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030 (USD Million)
  • Figure 11.60. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030 (USD Million)
  • Figure 11.61. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.62. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.63. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030 (USD Million)
  • Figure 11.64. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030 (USD Million)
  • Figure 11.65. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.66. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.67. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030 (USD Million)
  • Figure 11.68. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030 (USD Million)
  • Figure 11.69. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.70. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.71. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030 (USD Million)
  • Figure 11.72. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030 (USD Million)
  • Figure 11.73. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.74. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.75. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030 (USD Million)
  • Figure 11.76. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030 (USD Million)
  • Figure 11.77. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.78. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.79. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030 (USD Million)
  • Figure 11.80. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030 (USD Million)
  • Figure 11.81. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.82. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.83. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030 (USD Million)
  • Figure 11.84. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030 (USD Million)
  • Figure 11.85. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.86. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.87. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030 (USD Million)
  • Figure 11.88. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030 (USD Million)
  • Figure 11.89. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.90. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.91. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.92. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.93. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.94. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.95. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.96. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.97. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.98. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.99. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.100. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.101. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.102. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.103. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.104. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.105. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.106. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.107. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.108. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.109. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.100. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.111. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.112. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.113. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.114. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.115. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.116. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.117. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.118. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.119. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.120. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.121. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.122. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 11.123. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030 (USD Million)
  • Figure 11.124. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030 (USD Million)
  • Figure 11.125. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Figure 11.126. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030 (USD Million)
  • Figure 13.1. Survey Insights: Distribution of Respondents by Year of Establishment of Company
  • Figure 13.2. Survey Insights: Distribution of Respondents by Employee Size
  • Figure 13.3. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Continent-Wise)
  • Figure 13.4. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Country-Wise)
  • Figure 13.5. Survey Insights: Distribution by Designation and Seniority Level
  • Figure 13.6. Survey Insights: Distribution by Types of Services
  • Figure 13.7. Survey Insights: Distribution by Region of Operation
  • Figure 13.8. Survey Insights: Distribution by Type and Size of Clientele
  • Figure 13.9. Survey Insights: Distribution by Number of Projects
  • Figure 13.10. Survey Insights: Distribution by Proportion of Clients Outsourcing Regulatory Affairs-Related Services
  • Figure 13.11. Survey Insights: Distribution by Current and Future Market Opportunity

List Of Tables

  • Table 3.1. Key Drivers for Outsourcing Regulatory Affairs-Related Operations for Medical Devices
  • Table 3.2. Comparison of Key Factors for Regulatory CRO Selection for Medical Devices: Harvey Ball Analysis
  • Table 5.1. General Guidelines for Market Authorization and Reimbursement for Medical Devices
  • Table 5.2. Device Classification: US
  • Table 5.3. Device Classification: Canada
  • Table 5.4. Data Requirements and Characteristics of Province-wide HTA Processes in Canada
  • Table 5.5. Device Classification: Mexico
  • Table 5.6. Device Classification: Europe
  • Table 5.7. List of CE Directives in Europe
  • Table 5.8. Conformity Assessment Modules in Europe
  • Table 5.9. Device Classification: Australia
  • Table 5.10. Medical Devices Reimbursement and Pricing Approval Process: Australia
  • Table 5.11. Device Classification: Brazil
  • Table 5.12. Device Classification: China
  • Table 5.13. Device Classification: India
  • Table 5.14. Device Classification: Japan
  • Table 5.15. Medical Devices Reimbursement Categories
  • Table 5.16. Device Classification: Medsafe
  • Table 5.17. Device Classification: Singapore
  • Table 5.18. Device Classification: South Korea
  • Table 5.19. Device Classification: South Africa
  • Table 5.20. Device Classification: Thailand
  • Table 5.21. Medical Devices Regulatory Landscape Summary
  • Table 5.22. Medical Devices Reimbursement Landscape Summary
  • Table 6.1. Medical Devices Regulatory Affairs CROs: List of Players
  • Table 6.2. Medical Devices Regulatory Affairs CROs: Information on Area of Specialization
  • Table 6.3. Medical Devices Regulatory Affairs CROs: Information on Type of Regulatory Affairs-Related Services Offered
  • Table 6.4. Medical Devices Regulatory Affairs CROs: Information on Type of Additional Services Offered
  • Table 6.5. Medical Devices Regulatory Affairs CROs: Information on Device Class
  • Table 6.6. Medical Devices Regulatory Affairs CROs: Information on Type of Clientele
  • Table 6.7. Medical Devices Regulatory Affairs CROs: Information on Medical Device Regulatory Compliance Authorities
  • Table 6.8. Medical Devices Regulatory Affairs CROs: Information on Region of Operation
  • Table 6.9. Medical Devices Regulatory Affairs CROs: Information on Popular Therapeutic Areas
  • Table 7.1. Regulatory Affairs-Related Services for Medical Devices: List of Companies Profiled
  • Table 7.2. CTI: Company Snapshot
  • Table 7.3. CTI: Recent Developments and Future Outlook
  • Table 7.4. Medpace: Company Snapshot
  • Table 7.5. Medpace: Recent Developments and Future Outlook
  • Table 7.6. NAMSA: Company Snapshot
  • Table 7.7. NAMSA: Recent Developments and Future Outlook
  • Table 7.8. PAREXEL: Company Snapshot
  • Table 7.9. PAREXEL: Recent Developments and Future Outlook
  • Table 7.10. Premier Research: Company Snapshot
  • Table 7.11. Premier Research: Recent Developments and Future Outlook
  • Table 7.12. Underwriters Laboratory: Company Snapshot
  • Table 7.13. Underwriters Laboratory: Recent Developments and Future Outlook
  • Table 7.12. CROMSOURCE: Company Snapshot
  • Table 7.13. CROMSOURCE: Recent Developments and Future Outlook
  • Table 7.14. ICON: Company Snapshot
  • Table 7.15. ICON: Recent Developments and Future Outlook
  • Table 7.16. PharmaLex: Company Snapshot
  • Table 7.17. PharmaLex: Recent Developments and Future Outlook
  • Table 7.18. SteriPack: Company Snapshot
  • Table 7.19. SteriPack: Recent Developments and Future Outlook
  • Table 7.20. MIC Medical: Company Snapshot
  • Table 8.1. Benchmark Analysis: Peer Groups
  • Table 9.1. Comparison between Different Regulatory Outsourcing Models
  • Table 12.1. Medical Device Regulatory Affairs Outsourcing: Summary of the Report
  • Table 13.1. Survey Insights: Overview of Respondents
  • Table 13.2. Survey Insights: Designations and Seniority Levels
  • Table 13.3. Survey Insights: Types of Regulatory Affairs-Related Services
  • Table 13.4. Survey Insights: Region of Operation
  • Table 13.5. Survey Insights: Type and Size of Clientele
  • Table 13.6. Survey Insights: Distribution by Number of Projects
  • Table 13.7. Survey Insights: Proportion of Clients Outsourcing Regulatory Affairs-Related Services
  • Table 13.8. Survey Insights: Outsourcing Cost
  • Table 13.9. Survey Insights: Current and Future Market Opportunity
  • Table 14.1. A+ Science: Company Snapshot
  • Table 14.2. Atoz-Cro: Company Snapshot
  • Table 14.3. CROMSOURCE: Company Snapshot
  • Table 14.4. CW Research & Management: Company Snapshot
  • Table 14.5. HungaroTrial: Company Snapshot
  • Table 14.6. Metrics Research: Company Snapshot
  • Table 14.7. Vyomus Consulting: Company Snapshot
  • Table 15.1. Key Challenges within the Medical Device Supply Chain
  • Table 15.2. Healthcare Insurance Coverage in the US: Distribution by Type of Coverage
  • Table 15.3. Healthcare Insurance Coverage in Canada: Distribution by Type of Coverage
  • Table 15.4. Healthcare Insurance Coverage in the UK: Distribution by Type of Coverage
  • Table 15.5. Healthcare Insurance Coverage in France: Distribution by Type of Coverage
  • Table 15.6. Healthcare Insurance Coverage in Germany: Distribution by Type of Coverage
  • Table 15.7. Healthcare Insurance Coverage in Italy: Distribution by Type of Coverage
  • Table 15.8. Healthcare Insurance Coverage in Spain: Distribution by Type of Coverage
  • Table 15.9. Healthcare Insurance Coverage in Australia: Percentage Distribution by Type of Coverage
  • Table 15.10. Healthcare Insurance Coverage in China: Percentage Distribution by Type of Coverage
  • Table 15.11. Healthcare Insurance Coverage in Israel: Percentage Distribution by Type of Coverage
  • Table 15.12. Healthcare Insurance Coverage in Japan: Percentage Distribution by Type of Coverage
  • Table 15.13. Healthcare Insurance Coverage in New Zealand: Percentage Distribution by Type of Coverage
  • Table 15.14. Healthcare Insurance Coverage in South Korea: Percentage Distribution by Type of Coverage
  • Table 15.15. Healthcare Insurance Coverage in Taiwan: Percentage Distribution by Type of Coverage
  • Table 15.16. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment
  • Table 15.17. Medical Devices Regulatory Affairs CROs: Distribution by Company Size
  • Table 15.18. Medical Devices Regulatory Affairs CROs: Distribution by Geography
  • Table 15.19. Medical Devices Regulatory Affairs CROs: Distribution by Company Size and Geography
  • Table 15.20. Medical Devices Regulatory Affairs CROs: Distribution by Type of Regulatory Affairs-Related Services Offered
  • Table 15.21. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
  • Table 15.22. Medical Devices Regulatory Affairs CROs: Distribution by Type of Additional Services Offered
  • Table 15.23. Medical Devices Regulatory Affairs CROs: Distribution by Device Class
  • Table 15.24. Medical Devices Regulatory Affairs CROs: Distribution by Type and Size of Clientele
  • Table 15.25. Medical Devices Regulatory Affairs CROs: Distribution by Medical Device Regulatory Compliance Authorities
  • Table 15.26. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Region-wise)
  • Table 15.27. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Country-wise)
  • Table 15.28. Medical Devices Regulatory Affairs CROs: Distribution by Popular Therapeutic Areas
  • Table 15.29. Medpace: Annual Revenues, 2014-2018 (USD Million)
  • Table 15.30. PAREXEL: Annual Revenues, 2014-2017 (USD Million)
  • Table 15.31. Benchmark Analysis: Distribution by Region and Size of Employee Base
  • Table 15.32. Benchmark Analysis: North America, Peer Group I
  • Table 15.33. Benchmark Analysis: North America, Peer Group II
  • Table 15.34. Benchmark Analysis: North America, Peer Group III
  • Table 15.35. Benchmark Analysis: North America, Peer Group IV
  • Table 15.36. Benchmark Analysis: Europe, Peer Group V
  • Table 15.37. Benchmark Analysis: Europe, Peer Group VI
  • Table 15.38. Benchmark Analysis: Europe, Peer Group VII
  • Table 15.39. Benchmark Analysis: Europe, Peer Group VIII
  • Table 15.40. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group IX
  • Table 15.41. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group X
  • Table 15.42. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XI
  • Table 15.43. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XII
  • Table 15.44. Benchmark Analysis: Comparison across Peer Groups
  • Table 15.45. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.46. Medical Device Regulatory Affairs Outsourcing Market, 2019 and 2030: Distribution by Geography (USD Million)
  • Table 15.47. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.48. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.49. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.50. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.51. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.52. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.53. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.54. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.55. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.56. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.57. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.58. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.59. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.60. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.61. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.62. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.63. Medical Device Regulatory Affairs Outsourcing Market, 2019 and 2030: Distribution by Type of Regulatory Affairs-Related Service (USD Million)
  • Table 15.64. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.65. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.66. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.67. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.68. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.69. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.70. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.71. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.72. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.73. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030 (USD Million)
  • Table 15.74. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.75. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.76. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.77. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030 (USD Million)
  • Table 15.78. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.79. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.80. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.81. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.82. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.83. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.84. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.85. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.86. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.87. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.88. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.89. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.90. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.91. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.92. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.93. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.94. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.95. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.96. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.97. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.98. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.99. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.100. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.101. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.102. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.103. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.104. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.105. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.106. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.107. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.108. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.109. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.110. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.111. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.112. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.113. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.114. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.115. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.116. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.117. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.118. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.119. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.120. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.121. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.122. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.123. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.124. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.125. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.126. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.127. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.128. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.129. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.130. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.131. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.132. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.133. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.134. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.135. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.136. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.137. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.138. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.139. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.140. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.141. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030 (USD Million)
  • Table 15.142. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.143. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.144. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.145. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.146. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.147. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.148. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.149. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.150. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.151. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.152. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.153. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.154. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.155. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.156. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.157. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.158. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.159. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.160. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.161. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.162. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.163. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.164. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.165. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.166. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.167. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.168. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.169. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.170. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
  • Table 15.171. Survey Insights: Distribution of Respondents by Year of Establishment of Company
  • Table 15.172. Survey Insights: Distribution of Respondents by Employee Size
  • Table 15.173. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Continent-Wise)
  • Table 15.174. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Country-Wise)
  • Table 15.175. Survey Insights: Distribution by Designation and Seniority Level
  • Table 15.176. Survey Insights: Distribution by Types of Services
  • Table 15.177. Survey Insights: Distribution by Market Access
  • Table 15.178. Survey Insights: Distribution by Type and Size of Clientele
  • Table 15.179. Survey Insights: Distribution by Number of Projects
  • Table 15.180. Survey Insights: Distribution by Proportion of Clients Outsourcing Regulatory Affairs-Related Services
  • Table 15.181. Survey Insights: Distribution by Current and Future Market Opportunity

Listed Companies

The following companies / institutes / government bodies and organizations have been mentioned in this report.

  • 1. 1MED SA
  • 2. 4Clinics
  • 3. A+ Science
  • 4. Abbott
  • 5. ABIOGENESIS CLINPHARM
  • 6. ABX-CRO
  • 7. Accell Clinical Research
  • 8. Accredited Consultants
  • 9. Accutest Global
  • 10. Acorn Regulatory Consultancy Services
  • 11. Acrapack
  • 12. acromion
  • 13. aCROss Medical
  • 14. Activa Cro
  • 15. Actolis
  • 16. ADAX International
  • 17. Advanced Medical Research (AMR)
  • 18. Advena
  • 19. AE Performance Testing Lab
  • 20. Affinity Bio Partners
  • 21. Afra Pharma Consultant
  • 22. AG Mednet
  • 23. Aginko Research
  • 24. AICROS
  • 25. Al Tamimi
  • 26. Allied Clinical Management
  • 27. Allscripts Healthcare Solutions
  • 28. Alquest
  • 29. ALTIORA
  • 30. Amarex
  • 31. American Preclinical Services
  • 32. AmeRuss
  • 33. Amritt
  • 34. analyze & realize
  • 35. Andaman Medical
  • 36. Anteris Medical
  • 37. ANTRIX
  • 38. A-pharmaconsult
  • 39. apices
  • 40. APO Plus Station
  • 41. Appletree CI Group
  • 42. Arazy Group Consultants
  • 43. ARC Pharma
  • 44. Archemin
  • 45. Arlenda
  • 46. ARQon
  • 47. Asia Actual
  • 48. ATLANSTAT
  • 49. AtoZ-CRO
  • 50. Australian Healthcare Solutions
  • 51. Auxilife Scientific Services
  • 52. AVANTI
  • 53. AVIAD Life Sciences
  • 54. Axonal-Biostatem
  • 55. Azelix
  • 56. Barons Medical Consulting
  • 57. Beaufort
  • 58. Becton Dickinson
  • 59. Beijing JRJ Science and technology
  • 60. BIC Group
  • 61. BioAgile Therapeutics
  • 62. BIOCODEX Nordics
  • 63. BioFortis
  • 64. Biomapas
  • 65. Biomedical Regulatory Consulting
  • 66. Biomedical Strategy
  • 67. BioMotiv
  • 68. BioPlan
  • 69. Biorasi
  • 70. Bioreg Services
  • 71. Bioscience
  • 72. Biotech Regulatory Solutions
  • 73. BioTeknica
  • 74. BiTrial Clinical Research
  • 75. BLAU Pharmaceutical Service
  • 76. Boston Biomedical Associates (BBA)
  • 77. Boston MedTech Advisors
  • 78. Boston Scientific
  • 79. Brandwood CKC
  • 80. Bridge Pharm
  • 81. BSI
  • 82. Cactus Global
  • 83. Cardinal Health
  • 84. CardioMed Device Consultants
  • 85. Cardiovascular European Research Center (CERC)
  • 86. CARSL Consulting
  • 87. Catawba Research
  • 88. Cato Research (CATO)
  • 89. CC Clinical research Consultants
  • 90. Ceetox
  • 91. C'en Al Research
  • 92. CERES
  • 93. CHA Medical Group
  • 94. Charles River Laboratories
  • 95. ChemADVISOR
  • 96. Chemical Inspection and Regulation Service (CIRS)
  • 97. China Med Device
  • 98. Chris Freer Associates
  • 99. Clarivate Analytics
  • 100. ClinAudits
  • 101. ClinDatrix
  • 102. Clinical Device Group
  • 103. Clinical Research & Compliance Consulting
  • 104. Clinical Trial Data Services
  • 105. CliniExperts
  • 106. Clinilabs
  • 107. Clinipace
  • 108. Clinlogix
  • 109. Clinmark
  • 110. ClinMed Pharma
  • 111. ClinSync
  • 112. Clintec
  • 113. CMIC Group
  • 114. CMX Research
  • 115. Cobridge
  • 116. Commercial Eyes
  • 117. ComplianceAcuity
  • 118. Complya Consulting
  • 119. CONET
  • 120. Consultys Switzerland
  • 121. Convex
  • 122. Costello Medical
  • 123. Courante Oncology
  • 124. CPS Cortex
  • 125. Creganna Medical
  • 126. Criterium
  • 127. Cromos Pharma
  • 128. CROMSOURCE
  • 129. CROs NT
  • 130. Crown CRO
  • 131. CSSi LifeSciences
  • 132. CTI
  • 133. CTNT
  • 134. CurAccel
  • 135. CW Research & Management
  • 136. CYA Medical Device Consulting
  • 137. Dalia Givony, Regulatory & Clinical Consulting
  • 138. Databean
  • 139. Datapharm Australia
  • 140. Datavant
  • 141. Datavant
  • 142. De Groot Technical Services
  • 143. DEKRA
  • 144. devicia
  • 145. DH RegSys
  • 146. dicentra
  • 147. DiscGenics
  • 148. DKSH Marketing Services Spain
  • 149. dMed
  • 150. Donawa Lifescience Consulting
  • 151. Dor Pharmaceutical Services
  • 152. DP Clinical
  • 153. DSA Consultants
  • 154. DuPage Medical Group
  • 155. EAS Consulting Group
  • 156. EG Mont Brazil
  • 157. Eli Lily
  • 158. Emergo
  • 159. Engel, Hellyer & Partners
  • 160. EPIC Research
  • 161. Essilor
  • 162. ESTERN Medical
  • 163. Ethicare
  • 164. EuDRAcon
  • 165. Eurofins Scientific
  • 166. Eurotrials
  • 167. Evidilya
  • 168. Exalon
  • 169. ExecuPharm
  • 170. Factory CRO
  • 171. FDAInsight
  • 172. Fermish Clinical Technologies
  • 173. FGK Clinical Research
  • 174. FMD K&L
  • 175. Focal Point Research
  • 176. Fountain Medical Development (FMD)
  • 177. Fresenius Medical Care
  • 178. Freyr
  • 179. GCP-Service International
  • 180. GE Healthcare
  • 181. genae
  • 182. Genco Medical
  • 183. Genelife Clinical Research
  • 184. Genpact
  • 185. George Clinical
  • 186. Getz Healthcare
  • 187. GKM
  • 188. Global Pharma Tek
  • 189. Global Regulatory Affairs (GRA)
  • 190. Global Regulatory Partners
  • 191. Global Regulatory Services
  • 192. Green Building Japan (GBJ)
  • 193. Grove Group
  • 194. Gsap
  • 195. Gulf Medical Devices Consultancy
  • 196. Health Advances
  • 197. Health Sciences
  • 198. Healthcare International Partners
  • 199. HealthLink
  • 200. HingeClinica
  • 201. HungaroTrial
  • 202. I 3 CONSULTING
  • 203. ICBio
  • 204. ICON
  • 205. ICRC-Weyer
  • 206. ICTA
  • 207. idcOnic
  • 208. Illingworth Research Group
  • 209. INE G-MED (through G-MED North America)
  • 210. Innomar Strategies (a part of AmerisourceBergen)
  • 211. Inrextest
  • 212. Integrated Resources CRO Division
  • 213. Intel
  • 214. International HealthCare (IHC)
  • 215. Intertek Group
  • 216. Ipsum
  • 217. IQVIA
  • 218. Iris Pharma
  • 219. Ironstone Product Development
  • 220. IRW
  • 221. ISA HEALTH
  • 222. ITEC Services
  • 223. IVDeology
  • 224. IZiel Healthcare
  • 225. J Knipper
  • 226. Japan MDC (JMDC)
  • 227. Johnson & Johnson
  • 228. JSS Medical Research
  • 229. KCR
  • 230. KCRI
  • 231. KD&A
  • 232. Ken Block Consulting
  • 233. Kensington Swan
  • 234. Keystone Regulatory Services
  • 235. Kiana Systems
  • 236. Kinapse
  • 237. KLIFO
  • 238. Knoell
  • 239. Kobridge Consulting
  • 240. KPS Clinical Services
  • 241. L.S Marketing & Registration
  • 242. LabCorp
  • 243. Lambda Therapeutic Research
  • 244. Larix
  • 245. Lean RAQA
  • 246. Leon Research
  • 247. Li-Med RA & QA Experts
  • 248. Linical
  • 249. LINK Medical
  • 250. LIONBRIDGE
  • 251. LNAge
  • 252. MakroCare
  • 253. Malca Chen-Zion Group
  • 254. MANDALA International
  • 255. Mapi Group
  • 256. MasterControl
  • 257. MAXIS
  • 258. McCarthy Consultant Services
  • 259. McGee Pharma International (MPI)
  • 260. McMillan Research
  • 261. MD101 Consulting
  • 262. MD-Clinicals
  • 263. mdi Consultants
  • 264. mdi Europa
  • 265. MDP Solutions
  • 266. MED Institute
  • 267. Medelis
  • 268. Medfiles Group
  • 269. Medical Equipment Compliance Association
  • 270. Medidee
  • 271. MeDiNova Research
  • 272. MediqTrans
  • 273. Meditrial
  • 274. MEDITRIAL
  • 275. Meditrial Europe
  • 276. MedNet
  • 277. Medpace
  • 278. MedPass International
  • 279. MedQ Consultants
  • 280. Medtronic
  • 281. Medvance
  • 282. Meiji Pharmaceutical University (MPU)
  • 283. Mene Research
  • 284. Mericon
  • 285. Meshayu Consultants
  • 286. MethodSense
  • 287. Metrics Research
  • 288. MIC Medical
  • 289. Micren Healthcare
  • 290. Microsoft
  • 291. Mid-Link Consulting
  • 292. Mn Solutions
  • 293. Mobius Medical
  • 294. MolecularMD
  • 295. Morley Research Consortium
  • 296. Morula HealthTech
  • 297. Musculoskeletal Clinical Regulatory Advisers (MCRA)
  • 298. NAGLREITER
  • 299. NAMSA
  • 300. Navitas Life Sciences
  • 301. NCGS
  • 302. NEOMED Services
  • 303. Neopharm
  • 304. Neox Clinical Research
  • 305. Neozene
  • 306. Nerac
  • 307. New England Research Institutes (NERI)
  • 308. NHP Consulting
  • 309. Nordic Health Economics AB (NHE)
  • 310. Northlane Capital Partners
  • 311. Northside consulting
  • 312. Novartis
  • 313. NovaTrials
  • 314. Novem Healthcare
  • 315. Novotek
  • 316. Novum
  • 317. NSF International
  • 318. Nyprax Pharma
  • 319. O4 Research
  • 320. Obelis Group
  • 321. OmniComm Systems
  • 322. Onorach
  • 323. Operon Strategist
  • 324. OPIS
  • 325. Ora
  • 326. Osmunda
  • 327. Pace Analytical
  • 328. Pacific Bridge Medical
  • 329. Pacific Clinical Research Group (PCRG)
  • 330. Parexel
  • 331. PAREXEL Biotech
  • 332. Paxmed Interational
  • 333. Pearl Pathways
  • 334. Pepgra
  • 335. Perfect Pharmaceuticals Consultants
  • 336. Perfection-CRO
  • 337. Pharma to Market
  • 338. Pharmaceutical Regulatory Services
  • 339. Pharmaceutical Solutions
  • 340. Pharmaco-Kinesis
  • 341. Pharmahungary Group
  • 342. PharmaLex
  • 343. PharmaMed Global (through AJW Technology Consultants)
  • 344. PharmaMed Research
  • 345. PharmDedict
  • 346. PharmEng Regulatory Affairs
  • 347. PharmOut
  • 348. Phidea Group
  • 349. Pivotal
  • 350. PPD
  • 351. PQE Group
  • 352. PRA International
  • 353. Practice Fusion
  • 354. PRC Clinical
  • 355. Precision Medicine Group
  • 356. Premier Research
  • 357. Professional Regulatory Affairs
  • 358. Profil
  • 359. Promedica International
  • 360. ProMedoss
  • 361. ProPharma Group
  • 362. Prosoft Clinical
  • 363. ProTrials
  • 364. Proxima Clinical Research
  • 365. Pharmaceutical and Regulatory Services (PRSG)
  • 366. Q&R Canada
  • 367. QA Consulting
  • 368. QAdvis
  • 369. Qmed Consulting
  • 370. Qserve Group
  • 371. QST Consultations
  • 372. Q-Trials
  • 373. Qualitiso
  • 374. Qualtech Consulting
  • 375. Quanticate
  • 376. Quantum Solutions India
  • 377. Quantum Solutions India (QSI)
  • 378. QUNIQUE
  • 379. R & C Consulting Group
  • 380. R&G PharmaStudies
  • 381. R&Q
  • 382. RAMED
  • 383. RCQ Solutions
  • 384. RCRI
  • 385. ReadyClinical
  • 386. Reg-Affairs & QualiPractixis
  • 387. RegDesk
  • 388. Registrar Corp
  • 389. Regulatory Compliance Associates
  • 390. Regulatory Insight
  • 391. Regulatory Professionals
  • 392. Reimbursement Strategies
  • 393. Research Professionals
  • 394. RGL Research
  • 395. Rho
  • 396. Rook Quality Systems
  • 397. RQMIS
  • 398. RQSolutions
  • 399. RTI Health Solutions
  • 400. Safis Solutions
  • 401. Samsung Medical Center
  • 402. Saudi Telecom Company (STC)
  • 403. Scandinavian CRO
  • 404. Scandinavian Regulatory Services (SRS)
  • 405. Scope International
  • 406. SeerPharma
  • 407. Sentez CRO
  • 408. Seoul CRO
  • 409. SEQ
  • 410. SGS
  • 411. Shanghai QiSheng Business Consulting
  • 412. SHYFT Analytics
  • 413. Sidley Austin
  • 414. Siemens
  • 415. Simmons & Simmons
  • 416. Sipra Labs
  • 417. Sixmurs Group
  • 418. Society for Clinical Research Sites
  • 419. Southern Star Research
  • 420. SPARTA
  • 421. SPharm
  • 422. StarFish Medical
  • 423. STATKING Clinical Services
  • 424. SteriPack Group
  • 425. SterlingBio
  • 426. Strategic Compliance International
  • 427. StrugoPharm
  • 428. Stryker
  • 429. Sumika Chemical Analysis Service (SCAS)
  • 430. SunFlare
  • 431. Symbioteq
  • 432. Syneos Health
  • 433. Syntax
  • 434. Synteract
  • 435. TAB Clinical
  • 436. TCA Clinical Research
  • 437. TechnoSTAT
  • 438. Telecommunications Industry Association (TIA)
  • 439. The CLINICAL TRIAL Company Group
  • 440. The CRO Group
  • 441. The Integra Group
  • 442. The Society for Clinical Research Sites (SCRS)
  • 443. The Weinberg Group
  • 444. Thema Med
  • 445. Theo Manufacturing
  • 446. TheraGenesis
  • 447. TPIreg
  • 448. TRAC
  • 449. TransPerfect Life Sciences
  • 450. Trial Form Support International (TFS) (Acquired by Ratos)
  • 451. Turacoz Healthcare Solutions
  • 452. TÜV SÜD-Healthcare & Medical Devices
  • 453. UBC
  • 454. Ulmer Ventures
  • 455. Underwriters Laboratory (UL)
  • 456. Unikal Consultants
  • 457. Vantage BioTrials
  • 458. Vantage Consulting International
  • 459. Venn Life Sciences
  • 460. Veristat
  • 461. VOLER Biotech Consulting
  • 462. Volv
  • 463. Vyomus Consulting
  • 464. WCCT Global
  • 465. Wipro
  • 466. Wonderville
  • 467. WOODLEY BIOREG
  • 468. Wuxi AppTec
  • 469. Zeincro
  • 470. Zi-Medical
  • 471. Zimmer Biomet
  • 472. Zwiers Regulatory Consulting