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