The client is a USA based leading new drug development company focusing on the development and commercialization of branded specialty products. They required Regulatory support in filing original applications for USFDA and maintaining the life cycle of all the products. The objective was to coordinate with the CMC team to make quality submissions while dealing with the ad hoc submission requests.

Download the case the know more about how Freyr assisted the client to achieve submissions with zero error which resulted in swift approvals.