API Manufacturing for International Markets

An API manufacturer sought to supply key intermediates for Investigational New Drugs (INDs) to both the U.S. and EU markets. We commenced with a GAP analysis and full Quality System assessment, followed by a Manufacturing Process Risk Assessment to identify Critical Process Parameters (CPPs). Personnel training, qualification, and validation activities were implemented to bring the facility to required standards, culminating in GMP compliance and regulatory approvals for both target markets.