Regulatory affairs in healthcare industry, government and academia are involved with a wide range of products, such as: pharmaceuticals, medical devices, in vitro diagnostics, biologics and biotechnology, nutritional products, cosmetics, veterinary products, etc. Regulation involves extensive evaluation of a particular drug product to ensure protection of public health, promotion of the product, drug registration, marketing authorization, import and distribution, and pharmacovigilance. Regulatory affairs activities often result in considerable increase in the fixed costs for manufacturing as well as R&D companies for maintaining in-house resources. Life sciences, medical device and pharmaceutical companies are adopting a blended variable cost approach to optimize their outsourcing costs in spite of full-time staffing costs for distinct set of functions, products and programs. Major benefits that pharmaceutical, medical device and life science companies can recognize from regulatory affairs outsourcing include refocusing of staff on core competency and other key strategic activities, and cost effectiveness.
The global regulatory affairs outsourcing market report estimates the market size (Revenue US$ million – 2014 to 2021) and composition of this market on based on service types (clinical trial application and product registration, regulatory consultation and legal representation, regulatory submissions, regulatory writing and publishing, etc.) and forecasts growth trends (CAGR% – 2017 to 2021).
The global regulatory affairs outsourcing market report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments. The global regulatory affairs outsourcing market research report is divided by geography (regional and country based) into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World.
Major players operating in the global regulatory affairs outsourcing market and included in this report are Quintiles Transnational Holdings, Inc., Covance, Inc., Pharmaceutical Product Development, LLC, PAREXEL International Corporation, ICON plc, Charles River Laboratories International, Inc., WuXi AppTec, Criterium, Inc., Medpace, Inc., Promedica International, Accell Clinical Research, LLC, Clinilabs, Inc. and PRA International, Inc.