Regulatory affairs outsourcing are the services utilized by the pharmaceutical, medical as well as biotech devices manufacturing companies for gaining speedy regulatory approvals from several organizations. Mainly, regulatory affairs include activities that include drug master files, technical writing, and review of chemistry, manufacturing and controls, eCTD conversion, query management, investigational new drug maintenance, serious adverse events reporting, labeling, and drug shipment approvals for clinical trials. Additionally, outsourcing regulatory affairs activities to the contract research organizations offers cost efficiency, reduced regulatory submission time as well as quality control in the overall production process. Moreover, large companies address capacity problems along with lack of expertise in their internal departments through outsourcing to smaller mid-size companies. It also reduces additional work load and consolidates regulatory departments to avoid duplication of work.
Global Regulatory Affairs Outsourcing Market: Key Players
The research study includes profiles of leading companies operating in the global regulatory affairs outsourcing market. Key players profiled in the report include: Covance, Inc., Medpace, Inc., Pharmaceutical Product Development LLC, ICON Plc, Charles River Laboratories International, Inc., Accell Clinical Research, Wuxi AppTec, Genpact Ltd., PARAXEL International Corporation, and Criterium, Inc.
Drivers for the Global Regulatory Affairs Outsourcing Market:
According to current market condition, 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. Furthermore, increasing technological advancements along with the invention of innovative products at low costs as well as increasing spending from the IT services industry are envisioned to bolster the demand for the global regulatory affairs outsourcing market over the forecast period.
Opportunities for the Global Regulatory Affairs Outsourcing Market:
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. Apart from that, emerging economies are also likely to create lucrative opportunities in the global regulatory affairs outsourcing market.
Restrains for the Global Regulatory Affairs Outsourcing Market:
However, the risk associated with data security, technological advancement, which is leading to rapid pricing fluctuations, monitoring issues and lack of standardization are hampering the market growth at the global level.
Region Wise, Global Regulatory Affairs Outsourcing Market Analysis:
On the basis of region, global regulatory affairs outsourcing market includes North America, Europe, Asia Pacific, Latin America, Middle East and Africa. Geographically, North America held the highest regulatory affairs outsourcing market share owing to rising requirements in the region. Moreover, presence of big pharmaceutical and biotech companies seeking workload management is also favoring regional growth. Asia Pacific is expected to witness substantial growth in near future, owing to unmet needs of the huge population base, low labor cost, and improving healthcare infrastructure. North America region is followed by Asia pacific and Europe.
Global Regulatory Affairs Outsourcing Market: Product analysis
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Other Services
Global Regulatory Affairs Outsourcing Market: Application analysis
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
Global Regulatory Affairs Outsourcing Market: Region analysis
- North America
- Rest of Europe
- Asia Pacific
- South Korea
- Rest of Asia Pacific
- Latin America
- Rest of L.A.
- Middle East and Africa
- South Africa
- Rest of Middle East
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