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Services offered
Our Services

At KM Consulting, we specialize in CMC and Process Development.
Our expert team provides comprehensive support for drug products, ensuring a seamless transition from early-stage concept to final approval.

Drug Product Formulation and Process Development (Small Molecules)

- 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

Strategic support selecting and managing CDMO partners

- 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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KM Consulting - CMC and Process Development Services
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