Credence Pharma Consulting
Case Studies
NCE development & launch
Client: Boston, US based Biotech
Project: NCE Antidiabetic molecule demonstrated upper GIT absorption in preclinical models. Helped client to develop, scale-up and support Phase 1-3 CMC for Gastric retention modified release tablets. Helped tech-transfer to CMO to manufacture PV batches for NDA filing. NCE approved Jan, 2023
Injectable Generics
Client: KY, US based speciality generic
Project: Client faced development & tech-transfer challenges with 4 sterile injectable ANDA portfolio. CPC provided CMC and registration / exhibit batches manufacturing and regulatory filing support to a US based small generic company.
Due-diligence of US CDMO
Client: UK based Private Equity group
Project: PE group engaged CPC to provide technical and operational due-diligence for potential CDMO company based in North-east US.