Case Study: a China-based biopharmaceutical company achieves smooth IND approval in China with FREYR regulatory support

China-based Biopharmaceutical Company secures IND approval 4 days early with FREYR

The China-based biopharmaceutical company sought regulatory support from FREYR for a Cell and Gene Therapy (CGT) product's IND application in China. The client faced challenges in aligning documentation with the NMPA's evolving requirements and responding to complex queries for a cutting-edge therapy with limited regulatory precedent.

FREYR provided end-to-end regulatory operations support, including timely query responses and strategic consultation on CMC changes and clinical trial documents. FREYR's solution ensured a smooth IND approval on time, with responses submitted four days ahead of deadlines, facilitating the client's readiness for conditional approval and accelerating time-to-market.

China-based Biopharmaceutical Company