A South Korea-based, leading Active Pharmaceutical Ingredient (API) manufacturing company approached Freyr for Regulatory assistance to prepare and submit a Drug Master File (DMF) to the United States Food and Drug Administration (USFDA) in electronic Common Technical Document (eCTD) format, and subsequently, to the Health Authority.
Freyr’s Regulatory Affairs (RA) team conducted a comprehensive gap analysis of the Drug Master File (DMF) against the Generic Drug User Fee Act (GDUFA) and prepared the Initial Completeness Assessment (ICA) submission to the United States Food and Drug Administration (USFDA).
Download the proven case to discover how Freyr’s RA team supported the customer in preparing and submitting DMF to the Health Authority while offering invaluable guidance throughout the process.