【Case Study】IND Completion in 12 Months (Small-Molecule NCE)
Learn more about our CMC Capability IND Completion in 12 Months (Small-Molecule NCE) Program Type: Small-molecule New Chemical Entity (NCE)Scope: End-to-end CMC (API process development, analytics, GMP manufacturing, regulatory documentation)Outcome: IND approval achieved ~12 months from contract signing Project Overview Medicilon supported a small-molecule NCE program with fully integrated CMC services, enabling IND approval within […]