A US-based, leading generics pharma wholesale & distributing company reached out to Freyr for Regulatory support in the compilation and submission of the CBE 30 to the USFDA. The challenge was to review the CBE 30 content provided by the customer and evaluate the documents in the given timeframe. Freyr’s Regulatory Affairs (RA) team conducted the gap analysis of the documents received from the customer and resolved them by collaborating with multiple stakeholders. The submission was compiled, evaluated, and filed on time.
Decode how Freyr's RA team was able to evaluate and compile the documents to facilitate the submission of the CBE 30 to the US FDA within the timeframe.