Episode notes
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/
Keywords
clinical trialsinnovationssmall pharma companiesregulations startupspharma industryFDAManufacturing Chemistry Manufacturing and Controls CMC