Freyr had a client who was a USA-based generic pharmaceutical company looking for Regulatory support in filing original ANDA and Response to Query submissions. The project had to be completed in swift timelines. The team faced other challenges such as coordinating with the CMC team for publishing documents and the client being a new player in the generic market. With a two-step review process, Freyr’s dedicated team was successful in filing high-quality original ANDA and Response to Query submissions. The team-maintained transparency in the whole process by conducting timely meetings with the client and understanding the requirements.
Decode how Freyr filed the original ANDA and Response to Query submissions with zero errors and helped the client meet their business objectives by maintaining the lifecycles of all the products. Download the proven case.