The contract regulatory affairs-management services market for

Roots Analysis has done a detailed study on Medical Device CROs for Regulatory Affairs Management Market, 2019-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.
To order this 550+ page report, which features 245+ figures and 250+ tables, please visit this link
Key Market Insights 
  • Over 400 companies claim to possess the required expertise to offer regulatory affairs management-related services to medical device-focused business entities
  • The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of such firms are located in the developed geographies
  • Service providers are catering to a diverse clientele, enabling sponsors to compliance to the standards of both regional and international regulators
  • Owing to the high competition, companies involved in this domain are steadily expanding their capabilities in order to augment their respective service portfolios and comply to evolving industry benchmarks
  • CROs are actively engaged in expanding their global footprint in order to enable their clients to navigate the technical and regulatory complexities across various geographies
  • The medical device regulatory affairs outsourcing market is anticipated to grow at an annualized rate of 6.8%; the opportunity is likely to be distributed across different therapeutic areas and geographies
  • Based on prevalent and anticipated trends, the revenue share will vary across important market segments, such as different types of services, size of service provider and device class
For more information, please visit https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html
 
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 Company Size and Geography

6.3.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Area of Specialization

6.3.1.    Analysis by Area of Specialization

6.4.       CROs Offering Medical Device Regulatory Services: Information on Type of Regulatory Affairs-Related Services Offered

6.4.1.    Analysis by Type of Regulatory Affairs-Related Service Offered

6.4.2.    Analysis by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services           Offered

6.5.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type of  Additional Services Offered

6.5.1.    Analysis by Type of Additional Services Offered

6.6.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Device Class

6.6.1.    Analysis by Device Class

6.7.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type and Size of Clientele

6.7.1.    Analysis by Type and Size of Clientele

6.8.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Medical Device Regulatory Compliance Authorities

6.8.1.    Analysis by Medical Device Regulatory Compliance Authorities


6.9.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Region-wise)

6.9.1.    Analysis by Geographical Reach (Region-Wise)


6.10.     CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Country-wise)

6.10.1.  Analysis by Geographical Reach (Country-Wise)


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 Financial Information

7.2.4.3. Service Portfolio

7.2.4.4. 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. Intertek

7.3.3.1. Company Overview

7.3.3.2 Financial Information

7.3.3.3. Service Portfolio

7.3.3.4. Future Outlook


7.3.4. PharmaLex

7.3.4.1. Company Overview

7.3.4.2. Service Portfolio

7.3.4.3 Future Outlook

7.3.5. Société Générale de Surveillance (SGS)

7.3.5.1. Company Overview

7.3.5.2. Service Portfolio

7.3.5.3 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

7.4.1.3 Recent Developments


8. COMPETITIVE BENCHMARKING

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


9.3. Concluding Remarks


10. MEDICAL DEVICE REGULATORY AFFAIRS: KEY 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 Labeling-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 Risk Management Service, 2019-2030

11.5.9. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030

11.5.10. 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 Labeling-Related Services in North America, 2019-2030

11.8.14. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Europe, 2019-2030

11.8.15. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Asia-Pacific, 2019-2030

11.8.16. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-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 Risk Management Service in North America, 2

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