A client with strong Phase I results sought fast-track designation, where every month of review time mattered. Anticipating the opportunity, Pharmatech guided them to manufacture three full-scale Phase I lots—simplifying their CMC narrative, eliminating comparability risks, and allowing the same lots to carry into Phase II.
Impact for the client:
- Regulatory risk reduced
- Approval accelerated by 3 to 6 months
- Program advanced with zero CMC issues raised
