The client was a USA-based CRO specialized in dermatology and was looking for Regulatory support in the creation and submission of 30+ SPLs within three (03) months. Meeting the specified timelines was quite the challenge. The documents provided by the client were last updated in 2015, and there were many validation gaps. Freyr identified a talented pool of resources that was able to accomplish these activities in the stringent period. The SPL submissions were made per the latest USFDA regulations, and the client gained cost benefits of more than 50%.

Decode how Freyr offered compliant Regulatory services to ensure multiple SPL submissions to the USFDA while adhering to the new guidelines and ensuring effective validations. Download the proven case.