A South Korean pharmaceutical and consumer product company approached Freyr to perform literature monitoring and compile the reports as required by the US FDA. As the client was facing ambiguity on process flow to be followed and the Regulatory requirements of the FDA, it was challenging for them to find adequate Regulatory road maps as required by the US FDA.

Despite these obstacles, how did Freyr performed literature monitoring and submitted the reports? Decode with this proven case.

A Canadian pharmaceuticals/consumer products company approached Freyr for the creation of Annual Summary Reports (CASR) for four (4) products. Due to shortage of Regulatory information from the client in relation to previously submitted sequences, Freyr team had to import and validate sequences produced and submitted by another vendor. Furthermore, there were no Regulatory strategies in place to decipher the requirements for different regions to process the submissions.

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.

An American pharmaceutical company was looking for a Regulatory partner for authoring and finalizing the Periodic Adverse Drug Experience Reports (PADERs) for marketed drugs in the USA. The client had limitations in terms of insufficient information, which created various complexities in reviewing and providing compliant PADER reports.

Find out how Freyr meticulously streamlined the review process in accordance with the US FDA requirements and successfully delivered the reports in specified timelines. Download the proven case.