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Regulatory Affairs Outsourcing Market 2021 : Gaining fast Regulatory Approvals from Various Organizations

Regulatory affairs outsourcing market has grown significantly over the last decade. Increasing research and development expenditure in healthcare sector and increasing adoption of various growth strategies has boosted demand for regulatory outsourcing services in recent years. These services are majorly offered in the pharmaceutical and medical devices segment. Rising number of clinical trials is expected to fuel the Regulatory affairs outsourcing market growth over the forecast period.

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Rising implementation of strict regulations on the medical devices for supporting patient safety is expected to drive the regulatory affairs outsourcing demand over the forecast period. For instance, the European government, in April 2017, implemented latest Medical Device Regulation (MDR 2017/745) along with replacing existing two directives, the Active Implantable Medical Devices Directive and the Medical Devices Directive, for improving transparency via a medical devices European database along with a novel system of device traceability system, which is unique device identification based. Moreover, medical device players require updating their devices as per the latest regulations till May 2020.

Furthermore, major players are accepting various strategies including capacity expansions and partnerships to enhance the offerings within the market, which is expected to bolster growth of the global regulatory affairs outsourcing market. For instance, Parexel International Corporation, in March 2018, collaborated with CHA Medical Group for enhancing clinical development in early phase in Korea. This collaboration expanded regulatory service, clinical research by Parexel for biopharmaceutical companies.

Moreover, there are rising number of conferences and seminars for regulatory affairs assurance staffs, and companies of medical devices, especially mid-size and start-up and companies, for providing insights into manufacturers facing major challenges under the latest In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). For instance, the group the British Standards Institution (BSI), in May 2019, arranged MDR and IVDR regulations seminar for highlighting the regulatory requirements changes for manufacturers of medical devices and others.

Major players functioning in the market are laying emphasis on adoption of collaboration and acquisition strategies for expanding the product offerings for potential markets. For instance, ProPharma Group, Inc. in July 2018, acquired the regulatory affairs services provider in Netherlands, in the medical, pharmaceutical device and healthcare sectors – Xendo Holding B.V., based in Netherlands.

The prominent players in the Regulatory Affairs Outsourcing Market are WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.

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The global regulatory affairs outsourcing market is projected to witness a CAGR of 12.0% during the forecast period, due to rising business strategies adoption by market players for expanding their offerings. For instance, IQVIA Holdings Inc., in February 2019, introduced IQVIA Biotech suite, designed for offering commercial and clinical solutions to small biopharma and biotech companies. This suite provides analytical support for requirements regarding safety, compliance, pricing, and regulatory

On the basis of application, the segment of medical devices, in 2018, gained the dominant share in the global regulatory affairs outsourcing market, due to factors including upgrading the regulations of medical devices and increasing demand for affordable, advanced, and innovative medical devices. For instance, China’s National Medical Products Administration (NMPA), in August 2019, in China, expanded a pilot project for medical device registration for covering 21 various regions to develop advanced clinical devices.

On the basis of region, North America gained a dominant share in 2018, in the global regulatory affairs outsourcing market, due to increasing expenditure of R&D by biotech and pharma players. For instance, in 2016, as per the Pharmaceutical Research and Manufacturers of America, the industry of biopharmaceutics has been invested around US$ 90 Bn in the activities of research and development, in the U.S.

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Main points in Regulatory Affairs Outsourcing Market Report Table of Content

Chapter 1 Industry Overview

1.1 Definition

1.2 Assumptions

1.3 Research Scope

1.4 Market Analysis by Regions

1.5 Global Regulatory Affairs Outsourcing Market Size Analysis from 2021 to 2027

11.6 COVID-19 Outbreak: Regulatory Affairs Outsourcing Industry Impact

Chapter 2 Global Regulatory Affairs Outsourcing Competition by Types, Applications, and Top Regions and Countries

2.1 Global Regulatory Affairs Outsourcing (Volume and Value) by Type

2.3 Global Regulatory Affairs Outsourcing (Volume and Value) by Regions

Chapter 3 Production Market Analysis

3.1 Global Production Market Analysis

3.2 Regional Production Market Analysis

Chapter 4 Global Regulatory Affairs Outsourcing Sales, Consumption, Export, Import by Regions (2016-2021)

Chapter 5 North America Regulatory Affairs Outsourcing Market Analysis

Chapter 6 East Asia Regulatory Affairs Outsourcing Market Analysis

Chapter 7 Europe Regulatory Affairs Outsourcing Market Analysis

Chapter 8 South Asia Regulatory Affairs Outsourcing Market Analysis

Chapter 9 Southeast Asia Regulatory Affairs Outsourcing Market Analysis

Chapter 10 Middle East Regulatory Affairs Outsourcing Market Analysis

Chapter 11 Africa Regulatory Affairs Outsourcing Market Analysis

Chapter 12 Oceania Regulatory Affairs Outsourcing Market Analysis

Chapter 13 South America Regulatory Affairs Outsourcing Market Analysis

Chapter 14 Company Profiles and Key Figures in Regulatory Affairs Outsourcing Business

Chapter 15 Global Regulatory Affairs Outsourcing Market Forecast (2021-2027)

Chapter 16 Conclusions

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Last Updated: 24-Aug-2021