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Regulatory Affairs

 

The world of medicine continues to change and evolve at an ever-increasing rate, and a BioPoint Regulatory Affairs expert will be there to help guide you through the also-evolving regulatory climate. BioPoint works with its clients providing the appropriate expertise every step of the way.

Why BioPoint?

The 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.

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

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Regulatory Affairs Consulting Services

  • Regulatory Strategy
  • Regulatory Submission Planning
  • Advertising/Promotion Review and Compliance
  • Chemistry Manufacturing & Controls (CMC)
  • Product Labeling Development and Strategy
  • Medical Writing
  • 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