A US-based, leading generics pharmaceutical company approached Freyr for Regulatory assistance in the 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 under the given timeframe. Freyr’s Regulatory Affairs (RA) team worked with multiple stakeholders to compile and evaluate the documents and file the submission on time to help the customer meet their business objectives. 

Download the proven case to comprehend how Freyr was able to compile the CBE 30 within the given timeframe by review and evaluate the documents, identifying the gaps, and resolving them while ensuring compliance.