Is The FDA Chemistry Manufacturin...

Is The FDA Chemistry Manufacturing Controls Pilot Program Helpful For Pharma Startups?

Solutions OP Clinical Trials UK por Olga Peycheva
E35
3 oct 2025
18:53

Notas del episodio

This episode is an overview of the FDA Chemistry Manufacturing Controls Pilot Program and lessons learnt from the current participants in the pilot. It covers what is the scope of the pilot program and some of the unique challenges in manufacturing. Would that pilot be useful for small pharma companies and startups?

You can read our transcript here: https://solutionsop.co.uk/2025/10/09/is-the-fda-chemistry-manufacturing-controls-pilot-program-helpful-for-pharma-startups/

Palabras clave

clinical trials
innovations
small pharma companies
regulations
startups
pharma industry
FDA
Manufacturing
Chemistry Manufacturing and Controls CMC