A USA-based pharmaceutical company approached Freyr for assistance in filing original ANDA applications and submit them to the USFDA. The challenge was to carry out the validation process for the documents while managing last-minute documents changes. Apart from sticking to the narrow timelines, these activities presented several difficulties. Freyr assisted the client by providing a diverse set of Regulatory services complying with FDA standards.
Discover how Freyr offered Regulatory support and assisted the client by performing rigorous QC to meet compliance requirements and effectively delivered ANDA submissions on time. Download the proven case.