Regulatory Affairs

Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be analysed according to the Regulatory Affairs Guidelines. There are several Regulatory Affairs departments depending upon the countries within ever growing pace of companies. Global Harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

Market Analysis:

The global regulatory affairs outsourcing market is expected to reach USD 12.4 billion by 2025, according to a new report by Grand View Research, Inc. Outsourcing of regulatory affairs functions to CROs or other individual service providers offers life science companies the benefit to achieve cost efficiency and reduce the overall approval process time by eliminating delays associated with regulatory submission requirements. These benefits are primarily driving the outsourcing trend and hence impacting the market over the forecast period.

Related industries: Alexion Pharmaceuticals, Katalyst Healthcares & Life Sciences, Mallinckrodt, Stryker, Mylan, Genmab, Cepheid, Martin Marietta Materials.

Associations and societies:  Regulatory Affairs Professionals SocietySan Diego Regulatory Affairs NetwokDrug Information AssociationThe Organisation for Professionals in Regulatory AffairsAssociation of Regulatory Affairs Professionals.

  • Regulatory Guidelines
  • USFDA
  • MHRA
  • Regulations in Pharmacovigilance

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Regulatory Affairs Conference Speakers

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