Regulatory Affairs Consulting

Intrinsik’s scientific experts provide regulatory strategy and support from the pre-clinical stage through to market, including content authoring, and preparation, submission and maintenance of applications for registration of small molecules pharmaceuticals, biologics, natural health products (NHPs), dietary supplements, cosmetics, medical devices and food additives and ingredients in the United States, Europe and Canada.

Services:

  • Interaction with regulatory authorities on behalf of clients
  • Regulatory consultation meetings, including pre-submission meetings
  • Regulatory strategy
  • Product assessment and classification
  • Expedited approval pathways (e.g., fast-track, breakthrough therapy, priority review)
  • Orphan drug designation
  • Special protocol assessments
  • Pediatric plans
  • Clinical trials (IND, CTA)
  • United States NDA via 505(b)(1) and 505(b)(2) pathways
  • Canadian NDS, DIN, NHP PLA
  • EU MAA
  • Medical Device Applications
  • Drug Establishment Licence and Site Licence application support
  • Post approval and lifecycle management
  • Product label development and review
  • Claims assessment and promotional material review
  • eCTD publishing
  • United States agent and Canadian regulatory representative

 

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us