Regulatory Affairs

Regulatory strategy/submissions

  • All disciplines

    • CMC

    • Pharmacology/Toxicology

    • Clinical

    • General Strategy, including expedited and rare drug pathways

      • RMAT

      • Breakthrough

      • Fast Track

      • Accelerated Approval

        • RMAT-specific accelerated approval

      • Priority Review

      • Orphan Drug Designation

      • Rare Pediatric Disease Designation and Voucher

    • All types of meetings and briefing packages e.g., Type A, Type B, and Type C meetings

    • All types of regulatory submissions e.g., FDA IND/510k/BLA; pre-submissions (prepreIND; preIND; other)

    • '351' vs '361' HCT/Ps

      • Preparation for November 2020 FDA compliance deadline

    • Office of Combination Product Requests for Designation (RFD)s

      • Product jurisdiction e.g., ‘361’ HCT/P, medical device, biologic, combination product

    • Global e.g., Health Canada, EMA and National Competent Authorities, Japan, other.