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        Europe Healthcare Regulatory Affairs Outsourcing Market – By Service Type

1.3.2        Europe Healthcare Regulatory Affairs Outsourcing Market – By End User

1.3.3        Europe Healthcare Regulatory Affairs Outsourcing Market – By Country

2.           Europe Healthcare Regulatory Affairs Outsourcing Market – Key Takeaways

3.        Research Methodology

3.1         Coverage

3.2         Secondary Research

3.3         Primary Research

4.           Europe Healthcare Regulatory Affairs Outsourcing Market – Market Landscape

4.1         Overview

4.2         Expert Opinions

5.           Europe Healthcare Regulatory Affairs Outsourcing Market– Key Market Dynamics

5.1         Market Drivers

5.1.1        Increasing Regulatory Pressure on Healthcare Companies

5.1.2        Rise in Demand for Speedy Approval of New Products

5.2         Market Restraints

5.2.1        Lack 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        Surging Market Consolidation Activities

5.5         Impact Analysis

6.           Healthcare Regulatory Affairs Outsourcing Market – Europe Analysis

6.1         Europe Healthcare Regulatory Affairs Outsourcing Market Revenue Forecast and Analysis

7.           Europe 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.           Europe 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.           Europe Healthcare Regulatory Affairs Outsourcing Market – Country Analysis

9.1.1        Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Country (%)

9.1.1.1          Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

9.1.1.1.1          Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

9.1.1.1.2          Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Service Type (US$ Mn)

9.1.1.1.3          Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by End User (US$ Mn)

9.1.1.1.3.1       Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by Medical Device Companies (US$ Mn)

9.1.1.2          France Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

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

9.1.1.2.2          France Healthcare Regulatory Affairs Outsourcing : Market, By Service Type, 2019–2028 (USD Million)

9.1.1.2.3          France: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

9.1.1.2.3.1       France: Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies, 2019–2028 (USD Million)

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

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

9.1.1.3.2          UK: Contract Research Organization (CRO) Market, By Service Type, 2019–2028 (USD Million)

9.1.1.3.3          UK: Contract Research Organization (CRO) Market, by End User, 2019–2028 (USD Million)

9.1.1.3.3.1       UK: Contract Research Organization (CRO) Market, by Medical Device Companies, 2019–2028 (USD Million)

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

9.1.1.4.1          Italy: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.4.2          Italy: Healthcare Regulatory affairs outsourcing Market, By Service Type, 2019–2028 (USD Million)

9.1.1.4.3          Italy Healthcare Regulatory affairs outsourcing Market, by End User, 2019–2028 (USD Million)

9.1.1.4.3.1       Italy: Healthcare Regulatory affairs outsourcing Market, by Medical Device Companies, 2019–2028 (USD Million)

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

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

9.1.1.5.2          Spain: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

9.1.1.5.3          Spain: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

9.1.1.5.3.1       Spain: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

9.1.1.6          Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.6.1          Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

9.1.1.6.2          Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

9.1.1.6.3          Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

9.1.1.6.3.1       Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

10.        Impact Of COVID-19 Pandemic on Europe 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      KLIFO

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      ProPharma Group

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      Arriello Ireland Ltd.

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      DRA CONSULTING OY

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      Asphalion S.L

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      PAREXEL INTERNATIONAL CORPORATION

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      IQVIA Inc.

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

12.8      PHARMALEX GMBH

12.8.1     Key Facts

12.8.2     Business Description

12.8.3     Products and Services

12.8.4     Financial Overview

12.8.5     SWOT Analysis

12.8.6     Key Developments

12.9      ProductLife Group

12.9.1     Key Facts

12.9.2     Business Description

12.9.3     Products and Services

12.9.4     Financial Overview

12.9.5     SWOT Analysis

12.9.6     Key Developments

12.10   Voisin Consulting Life Sciences (VCLS)

12.10.1  Key Facts

12.10.2  Business Description

12.10.3  Products and Services

12.10.4  Financial Overview

12.10.5  SWOT Analysis

12.10.6  Key Developments

12.11   Azierta Contract Science Support Consulting

12.11.1  Key Facts

12.11.2  Business Description

12.11.3  Products and Services

12.11.4  Financial Overview

12.11.5  SWOT Analysis

12.11.6  Key Developments

13.        Appendix

13.1      About The Insight Partners

13.2      Glossary of Terms

LIST OF TABLES

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

Table 2.             Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Service Type US$ Mn)

Table 3.             Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by End User US$ Mn)

Table 4.             Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by Medical Device Companies US$ Mn)

Table 5.             France: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

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

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

Table 8.             UK: Contract Research Organization (CRO) Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

Table 9.             UK: Contract Research Organization (CRO) Market, by End User – Revenue and Forecast to 2028 (USD Million)

Table 10.          UK Contract Research Organization (CRO) Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

Table 11.          Italy: Healthcare Regulatory affairs outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

Table 12.          Italy: Healthcare Regulatory affairs outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

Table 13.          Italy Healthcare Regulatory affairs outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

Table 14.          Spain: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

Table 15.          Spain: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

Table 16.          Spain Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

Table 17.          Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

Table 18.          Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

Table 19.          Rest of Europe Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

Table 20.          Organic Developments in the Healthcare Regulatory Affairs Outsourcing Market

Table 21.          Inorganic Developments in the Healthcare Regulatory Affairs Outsourcing Market

Table 22.          Glossary of Terms, Healthcare Regulatory Affairs Outsourcing Market

LIST OF FIGURES

Figure 1.           Europe Healthcare Regulatory Affairs Outsourcing Market Segmentation

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

Figure 3.           Europe Healthcare Regulatory Affairs Outsourcing Market Overview

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

Figure 5.           Germany to Show Significant Growth During Forecast Period

Figure 6.           Europe PEST Analysis

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Figure 29.        Europe: Healthcare Regulatory Affairs Outsourcing Market Revenue Overview, by Country, 2021 (US$ MN)

Figure 30.        Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Country (%)

Figure 31.        Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

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

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

Figure 34.        Italy: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (USD Million)

Figure 35.        Spain: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

Figure 36.        Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

Figure 37.        Impact of COVID-19 Pandemic in European Country Markets