Regulatory involves extensive evaluation of a particular product to ensure protection of public health, marketing authorization, import and distribution and in order to meet safety and efficacy of products, market player ensures the product meets all the regulatory requirements. The regulatory affair outsourcing companies are responsible for keeping track about the regulatory requirements specific to the regions in order to ensure that company successfully launches and commercialize pharmaceutical product, medical device, biologics and functional foods. If the product does not meet the regulatory guidelines, product can be recalled resulting in huge revenue loss.
Number of small and large pharmaceutical and biopharmaceutical companies are relying on CRO”s and other drug development activities so as to expand their territories which is considered as major driving factor for growth of the global regulatory affairs outsourcing market. In addition, increasing funding by market player in research and development activities to develop biosimilar, orphan and generic drug is anticipated to further drive growth of the global regulatory affairs outsourcing market over the forecast period.
However, the improvement in the process focusing in pre marketing and post marketing activities, and reduced regulatory service cost is expected to create new opportunities for major players in the global regulatory affairs outsourcing market over the forecast period.
The global regulatory affairs outsourcing market report has been segmented on the basis of service, and region. On the basis of region, the global regulatory affairs outsourcing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
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North America market dominates the global regulatory affairs outsourcing market in terms of revenue contribution as compared to that of markets in other regions. Europe accounts for second-largest revenue share contribution to the global regulatory affairs outsourcing market, followed by markets in Latin America, Asia Pacific, and Middle East & Africa respectively. The market in Asia Pacific is projected to register comparatively faster growth in terms of revenue over the forecast period, owing to growing number of regulatory affairs out-sourcing companies and availability of skilled workforce.
Some prominent players in the global sterilization equipment market are Genpact Ltd., Criterium, Inc., Accell Clinical Research, PARAXEL International Corporation, ICON Plc, Covance, Inc., Charles River Laboratories International, Inc., Pharmaceutical Product Development (PPD), LLC, Medpace, Inc., and Wuxi AppTec.
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