The client, a U.S. based contract manufacturing company, approached Freyr to review the raw data, impact analysis of the changes, compilation of the affected sections including administrative documents and submission to the US FDA. Freyr had two challenges, firstly the client didn’t have Regulatory expertise and secondly, the activity had to be completed within the Regulatory timelines. Freyr successfully completed both the challenges and assisted the publishing team to avoid submission delay.
How did Freyr complete the process within short time frame? Read the case.