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Tag: GMP

March 1, 2025

Preparation of an Investigational New Drug (IND) Application

Clinical, CMC, Knowledge, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Risk Management

Stuart R. Gallant, MD, PhD A pharmaceutical company begins development of a new drug by screening dozens or even thousands of molecules to find the…

Stuart Gallant
November 9, 2022

Selecting and Working With a Contract Manufacturer

CMC, Knowledge, Logistics, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Raw Materials, Risk Management

Stuart R. Gallant, MD, PhD The Convention on Pharmaceutical Ingredients (CPhI) was just held in Frankfurt.  As the self-described “leading networking event for pharmaceutical industry,”…

Stuart Gallant
January 17, 2022

Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)

CMC, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Raw Materials, Uncategorized

Stuart R. Gallant, MD, PhD In the first post of this series, raw materials risk analysis was discussed.  In the second post of this series,…

Stuart Gallant
January 17, 2022

Risk Assessment of Raw Materials and Contact Materials (1 of 2)

CMC, Pharmaceutical Manufacturing, Planning, Raw Materials

Stuart R. Gallant, MD, PhD One of the first steps in a pharmaceutical development project is selection of chemicals.  For the development team, it may…

Stuart Gallant

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