Case Study: a U.S.-based pharmaceutical company achieves error-free South Korea regulatory publishing with Freyr

a U.S.-based pharmaceutical company achieves zero submission errors with FREYR and cuts costs by 70%

A U.S.-based pharmaceutical company required end-to-end regulatory publishing support for eCTD submissions of its oral and parenteral products in South Korea. The client faced challenges with complex local requirements, frequent last-minute document changes, and the need to ensure all materials complied with FDA PDF specifications, which risked their submission timelines and overall compliance. They engaged FREYR for its regulatory publishing services.

FREYR implemented a comprehensive solution that included a detailed tracking system for document versions, rigorous quality checks at every stage, and close coordination with the client's CRO. This approach ensured a valid and error-free submission. The results delivered by FREYR included zero errors or warnings during the submission, a reduced overall turnaround time, and cost benefits of upwards of 70%.