- Formulation and Process Design (Phase appropriate, from pre-clinical to approval for
commercialization)
- Author / review of Drug Product sections of submission dossiers (IND, IMPD, NDA, ANDA and
others upon request)
- In person monitoring of batch manufacturing
- Online training on Drug Product Formulation and Process Development
- Advise the sponsor on the selection of the best CDMO partner
- Author / review of Requests for Proposals (RFP)
- Attend technical calls with the selected CDMO, advising the technical teams on executable choices and best path forward
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