TABLE OF CONTENTS

1.           Introduction

1.1         Scope of the Study

1.2         The Insight Partners Research Report Guidance

1.3         Market Segmentation

1.3.1        North America Healthcare Regulatory Affairs Outsourcing Market – By Service Type

1.3.2        North America Healthcare Regulatory Affairs Outsourcing Market – By End User

1.3.3        North America Healthcare Regulatory Affairs Outsourcing Market – By Country

2.           North America Healthcare Regulatory Affairs Outsourcing Market – Key Takeaways

3.        Research Methodology

3.1         Coverage

3.2         Secondary Research

3.3         Primary Research

4.           North America Healthcare Regulatory Affairs Outsourcing Market – Market Landscape

4.1         Overview

4.1.1        North America – PEST Analysis

4.2         Expert Opinions

5.           North America Healthcare Regulatory Affairs Outsourcing Market– Key Market Dynamics

5.1         Market Drivers

5.1.1        Rising Regulatory Pressure on Healthcare Companies

5.1.2        Escalating Demand for Speedy Approval of New Products

5.2         Market Restraints

5.2.1        Dearth of Skilled Professionals

5.3         Market Opportunities

5.3.1        Advancements in Specialty Therapies, Orphan Drugs, and Personalized Medicines

5.4         Future Trends

5.4.1        Soaring Market Consolidation Activities

5.5         Impact Analysis

6.           Healthcare Regulatory Affairs Outsourcing Market – North America Analysis

6.1         North America Healthcare Regulatory Affairs Outsourcing Market Revenue Forecast and Analysis

7.           North America Healthcare Regulatory Affairs Outsourcing Market Analysis – By Service Type

7.1         Overview

7.2         Healthcare Regulatory Affairs Outsourcing Market, by Service Type (2021 and 2028)

7.3         Regulatory and Scientific Strategy Development

7.3.1        Overview

7.3.2        Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.4         Medical and Scientific Writing

7.4.1        Overview

7.4.2        Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.5         eCTD and E-Submissions

7.5.1        Overview

7.5.2        eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.6         Data Management Services

7.6.1        Overview

7.6.2        Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.7         Life Cycle Management Services

7.7.1        Overview

7.7.2        Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.8         Pharmacovigilance

7.8.1        Overview

7.8.2        Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.9         Chemistry Manufacturing and Controls (CMC) Services

7.9.1        Overview

7.9.2        Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.10      Regulatory Labelling

7.10.1     Overview

7.10.2     Regulatory Labelling : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

7.11      Regulatory Artwork Services

7.11.1     Overview

7.11.2     Regulatory Artwork Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.           North America Healthcare Regulatory Affairs Outsourcing Market Analysis – By End User

8.1         Overview

8.2         Healthcare Regulatory Affairs Outsourcing Market, by End-User (2020 and 2028)

8.3         Pharmaceutical Companies

8.3.1        Overview

8.3.2        Pharmaceutical Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.4         Biotechnology Companies

8.4.1        Overview

8.4.2        Biotechnology Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.5         Medical Device Companies

8.5.1        Overview

8.5.2        Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

8.5.2.1          Medical Device Software (SaMD) Market

8.5.2.1.1          Overview

8.5.2.1.2          Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.2          Medical Device Materials & Biomaterials Market

8.5.2.2.1          Overview

8.5.2.2.2          Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.3          Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market

8.5.2.3.1          Overview

8.5.2.3.2          Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.4          Medical Device Electro mechanics Market

8.5.2.4.1          Overview

8.5.2.4.2          Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.5          Medical Device Substance Based Market

8.5.2.5.1          Overview

8.5.2.5.2          Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

8.5.2.6          Medical Device of Combination Product (DDC) Market

8.5.2.6.1          Overview

8.5.2.6.2          Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

9.           North America Healthcare Regulatory Affairs Outsourcing Market – Country Analysis

9.1         Overview

9.1.1        North America: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

9.1.1.1          US: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.1.1          US: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.1.2          US Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

9.1.1.1.3          US Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

9.1.1.1.3.1       US Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

9.1.1.2          Canada: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.2.1          Canada: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.2.2          Canada Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

9.1.1.2.3          Canada Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

9.1.1.2.3.1       Canada Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

9.1.1.3          Mexico: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.3.1          Mexico: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.3.2          Mexico Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

9.1.1.3.3          Mexico Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

9.1.1.3.3.1       Mexico Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

10.        Impact Of COVID-19 Pandemic on North America Healthcare Regulatory Affairs Outsourcing Market

10.1      Overview

11.        Industry Landscape

11.1      Overview

11.2      Organic Developments

11.2.1     Overview

11.3      Inorganic Developments

11.3.1     Overview

12.        Company Profiles

12.1      ProPharma Group

12.1.1     Key Facts

12.1.2     Business Description

12.1.3     Products and Services

12.1.4     Financial Overview

12.1.5     SWOT Analysis

12.1.6     Key Developments

12.2      Arriello Ireland Ltd.

12.2.1     Key Facts

12.2.2     Business Description

12.2.3     Products and Services

12.2.4     Financial Overview

12.2.5     SWOT Analysis

12.2.6     Key Developments

12.3      PAREXEL INTERNATIONAL CORPORATION

12.3.1     Key Facts

12.3.2     Business Description

12.3.3     Products and Services

12.3.4     Financial Overview

12.3.5     SWOT Analysis

12.3.6     Key Developments

12.4      IQVIA Inc.

12.4.1     Key Facts

12.4.2     Business Description

12.4.3     Products and Services

12.4.4     Financial Overview

12.4.5     SWOT Analysis

12.4.6     Key Developments

12.5      PHARMALEX GMBH

12.5.1     Key Facts

12.5.2     Business Description

12.5.3     Products and Services

12.5.4     Financial Overview

12.5.5     SWOT Analysis

12.5.6     Key Developments

12.6      ProductLife Group

12.6.1     Key Facts

12.6.2     Business Description

12.6.3     Products and Services

12.6.4     Financial Overview

12.6.5     SWOT Analysis

12.6.6     Key Developments

12.7      Voisin Consulting Life Sciences (VCLS)

12.7.1     Key Facts

12.7.2     Business Description

12.7.3     Products and Services

12.7.4     Financial Overview

12.7.5     SWOT Analysis

12.7.6     Key Developments

13.        Appendix

13.1      About The Insight Partners

13.2      Glossary of Terms

LIST OF TABLES

Table 1.             North America Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecast to 2028 (US$ Million)

Table 2.             US Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

Table 3.             US Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

Table 4.             US Healthcare Regulatory Affairs Outsourcing Devices Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

Table 5.             Canada Healthcare Regulatory Affairs Outsourcing Market, by Service Type -Revenue and Forecast to 2028 (USD Million)

Table 6.             Canada Healthcare Regulatory Affairs Outsourcing Market, by End User - Revenue and Forecast to 2028 (USD Million)

Table 7.             Canada Healthcare Regulatory Affairs Outsourcing Devices Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

Table 8.             Mexico Healthcare Regulatory Affairs Outsourcing Market, by Service Type -Revenue and Forecast to 2028 (USD Million)

Table 9.             Mexico Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

Table 10.          Mexico Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

Table 11.          Organic Developments in the Healthcare Regulatory Affairs Outsourcing Market

Table 12.          Inorganic Developments in the Healthcare Regulatory Affairs Outsourcing Market

Table 13.          Glossary of Terms, Healthcare Regulatory Affairs Outsourcing Market

LIST OF FIGURES

Figure 1.           North America Healthcare Regulatory Affairs Outsourcing Market Segmentation

Figure 2.           North America Healthcare Regulatory Affairs Outsourcing Market Segmentation, By Country

Figure 3.           North America Healthcare Regulatory Affairs Outsourcing Market Overview

Figure 4.           Medical & Scientific Writing Segment Held the Largest Share of the Service Type Segment in North America Healthcare Regulatory Affairs Outsourcing Market

Figure 5.           US to Show Significant Growth During Forecast Period

Figure 6.           North America PEST Analysis

Figure 7.           North America Healthcare Regulatory Affairs Outsourcing Market Impact Analysis of Driver and Restraints

Figure 8.           North America Healthcare Regulatory Affairs Outsourcing Market – Revenue Forecast and Analysis – 2019- 2028

Figure 9.           North America Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by Service Type (2020 and 2028)

Figure 10.        North America Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 11.        North America Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 12.        North America eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 13.        North America Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 14.        North America Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 15.        North America Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 16.        North America Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 17.        North America Regulatory Labelling: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 18.        North America Regulatory Artwork Services : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 19.        North America Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by End-User (2020 and 2028)

Figure 20.        North America Pharmaceutical Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 21.        North America Biotechnology Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 22.        North America Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 23.        North America Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 24.        North America Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 25.        North America Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 26.        North America Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 27.        North America Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 28.        North America Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

Figure 29.        North America: Healthcare Regulatory Affairs Outsourcing Market, by Key Country – Revenue (2021) (USD Million)

Figure 30.        North America: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

Figure 31.        US: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

Figure 32.        Canada: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

Figure 33.        Mexico: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)