The client was a USA-based leading pharmaceutical company looking for Regulatory support in making IND submissions to the CDSCO. There were several challenges, such as tracking versions of frequently changed documents, high volume of review documents, and stringent timelines. Freyr was able to accomplish granular document level publishing and a detailed tracking system in addition to high-quality submissions. A team of publishing experts validated the source documents using appropriate tools, thus resulting in zero errors and warnings.
Explore Freyr’s expertise in meeting the deadlines set by the client and maintaining high-quality IND submissions using a compliant Regulatory pathway. Download the proven case.