A top generic pharmaceutical company approached Freyr for the creation of Periodic Adverse Drug Experience Reports (PADER). Client had no clarity on the FDA’s Regulatory requirements with respect to PADER. At the same time, they had to deal with stringent timelines defined by the Regulatory Agency. Apart from meeting the narrow timelines, the review process of the PADER reports presented multiple bottlenecks which are complex and tedious.
Discover how Freyr overcame the obstacles through strategic planning and provided Regulatory PADER reviewing services. Download the proven case.