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Regulatory Affairs

regulatory-affairsThe Life Sciences industry is heavily regulated. Medicines would never reach market without the expertise of regulatory professionals to ensure products in development are meeting global regulatory standards. At BioPoint we understand the importance of properly navigating a complex global regulatory arena.¬†We have a diverse global network of regulatory affairs specialists and experts available to support our clients’ development lifecycle from preclinical through product approval.

Comprehensive Regulatory Affairs Consulting Services

BioPoint is well-positioned to provide a high-impact regulatory affairs professional or a well-rounded team, to help deliver client-driven solutions in:

  • Regulatory strategic consulting
  • Regulatory submission consulting
  • Advertising/promotion review and compliance
  • Chemistry Manufacturing & Controls (CMC)
  • Product labeling development and strategy
  • Clinical trial authorizations, maintenance and trial support
  • Orphan drug and humanitarian device applications
  • Competitive and regulatory intelligence
  • Regulatory authority meeting preparation and facilitation
  • Pharmacovigilance processes
  • Marketing applications
  • Launch and post-approval activities

With such a wide range of services and areas of expertise, BioPoint truly stays with its clients every step of the way. The world of medicine continues to change and evolve at an ever-increasing rate, and a BioPoint regulatory affairs specialist will be there to help guide you through the also-evolving regulatory climate.

Do You Need a Regulatory Affairs Professional to Work With Your Company?

For more information on our regulatory consulting services and how we can make them work for you, please contact us at (781) 218-3790 or online. Our regulatory affairs specialists are ready to help your product reach its ultimate goal.

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