Regulatory Affairs Consulting

Intrinsik’s scientific and regulatory consultants provide 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, biologics, cell and gene therapies, natural health products (NHPs), and cosmetics in the United States, Europe and Canada.

Services:

• Lead teams in North American Authority Meetings (FDA, HC)
• 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:
  • Regulatory submission to Health Canada – Clinical Trial Application (CTA)
  • Regulatory submission to U.S. Food and Drug Administration – Investigational New Drug (IND)
• United States – U.S. Food and Drug Administration:
  • New Drug Application (NDA) via 505(b)(1) and 505(b)(2) pathways
• Canada – Health Canada:
  • New Drug Submission (NDS)
  •  Drug Identification Number (DIN)
  • Natural Health Product (NHP)
  • Product Licence Application (PLA)
• EU MAA
• 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