Regulatory Affairs (US/Intl)

 

The Regulatory Affairs group at Benchmark has extensive knowledge about the jurisdiction and regulation of biological products both within the US and internationally.  This ever current knowledge base provides clients with up-to-date advice at any and all points of the product development process; resulting in timely, cost effective, and successful product licensing.

Regulatory Affairs Services Highlights

  • Excellent reputation and relationships with regulatory authorities
  • Effective communication with regulatory authorities
  • Expert development of streamlined product-licensing plans
  • Preparation and maintenance of regulatory submissions
  • Regulatory strategies to facilitate product authorization
  • Skilled technical writing
  • Many others upon request…

International Regulatory Support

  • Dossier Preparation
  • Legalization
  • Translation
  • Expert Opinion Report Writing
  • More…

Please contact us for more details.