A US-based, leading CMO for pharma and consumer products company approached Freyr for Regulatory support in compiling, evaluating, and submitting general correspondence to the United States Food and Drug Administration (USFDA). The project involved reviewing various documents from the customer, identifying the gaps, and compiling the relevant data required for the general correspondence.
Freyr’s Regulatory Affairs team helped the customer meet their business goals by working within tight timelines and ensuring that the updated documents were verified against the Orange Book before submitting the package to the Agency.
Discover how Freyr filed the general correspondence submission to the United States Food and Drug Administration (USFDA) while ensuring compliance. Download the proven case.