A US-based, leading generics pharmaceutical company approached Freyr for Regulatory support in the submission of the PADER to the US FDA. The project presented several challenges such as reviewing the PADER content provided by the customer and evaluating the documents within narrow timelines. Freyr’s RA team evaluated the documents thoroughly and identified the gaps. These were resolved and then sent to the client for confirmation, post which the PADER was submitted to the Agency before the specified time.
Download the proven case to gain a better understanding of how Freyr's RA team was able to compile and evaluate the PADER content to maintain product compliance and continuity in the US market.