Case Study: a Switzerland-based biopharmaceutical company achieves timely BLA sample testing in China with Freyr regulatory operations support

Switzerland-based Biopharmaceutical Company completes BLA sample testing in China with FREYR

A Switzerland-based biopharmaceutical company partnered with FREYR to address the challenge of securing regulatory operations support for a monoclonal antibody product in China. The client faced strict timelines and a complex documentation review process aligned with evolving NMPA requirements, which risked significant delays to their BLA submission without proper regulatory alignment.

FREYR implemented a comprehensive solution that included coordinating test sample and dossier preparation, managing sample import to the NMPA test center, and handling all queries. Through proactive communication and risk identification, FREYR ensured the sample testing was completed per all requirements. This successful execution provided timely support for the BLA review process, minimizing delays and optimizing the regulatory pathway for the client in the Chinese market.