The U.S. based pharmaceutical company specializing In Niche Generics consulted Freyr for the project that included onsite service for review of the raw data, Gap Analysis of the draft CTD sections and compilation of entire ANDA package for submission to USFDA. The client had minimal knowledge about the submission requirements to the USFDA as this was their first submission.
How did Freyr support the client? What were the different solutions offered by the Freyr team? Read the case.