Case Study: a South Korea/China-based biopharma company achieves IND approval in China with FREYR’s sample test and regulatory support

South Korea/China-Based Biopharma Company secures IND approval with FREYR

The South Korea/China-based biopharma company faced a significant challenge when the approval process for its hormone drug in China was halted. This was due to complex technical issues identified by an NMPA test center, which the client lacked the in-country expertise to resolve, stalling their IND clearance. They engaged FREYR for regulatory operations and sample test support.

FREYR engaged directly with the NMPA test center to identify the root cause of the technical problems and coordinated with global teams to resolve all concerns. This solution provided the necessary clarity and direction to move the process forward. As a result, FREYR successfully resolved the issues, enabling the client to obtain IND approval and continue their regulatory journey in China.