Regulatory Affairs – Regulatory Designations/Incentives

Drafting, reviewing and advising on the right data and justifications to secure major regulatory designations notably:

  • Orphan Drug Designations (ODDs)
  • Innovative Licensing and Access Pathway (ILAP) – MHRA
  • PRIority MEdicines (PRIME) – EMA
  • Regenerative Medicine Advanced Therapy (RMAT), Fast Track and Breakthrough Therapy Designations – US FDA
Expertise and support with other ATMP-specific procedures notably:
  • ATMP Classifications
  • ATMP Certifications

info@biocellgeneregconsulting.com