A USA-based generic drug manufacturer sought Regulatory support with the review of the Discipline Response Letter (DRL) and strategy in preparation of response package, publishing, and submission to the FDA for ANDA approval. Complexities in handling labeling queries to the USFDA and short timelines for submission were a few of the challenges Freyr had to face to take up the project.

Download the proven case to decode how successfully Freyr executed the strategies to meet the Regulatory requirements and completed submissions on time.