A US-based contract research organization approached Freyr seeking support for ANDA re-submission and a thorough review of Module 2 and 5. Besides the stringent submission timelines, too many review iterations and last-minute modifications. However, Freyr provided expedited services in reviewing the submitted sequences from the RTR perspective and drafted the RTR response for each Agency query.
Discover how Freyr aided with the ANDA re-submission. Download the proven case.