The client was a USA-based global leader in innovating pathways for 505 (b)(2) and ANDA approvals and was seeking labeling and artwork Regulatory support for a New Drug Application. The project had several challenges, such as lack of first-hand clinical and non-clinical data, stringent timelines, and an absence of knowledge of the local regulations. Freyr, with a team of its Regulatory experts, was able to create the USPI based on the PLR and developed and reviewed the promotional material. Freyr designed compliant labeling documents per the current guidelines of the USFDA and reviewed the artwork in a timely manner.
Explore how Freyr was able to offer Regulatory support to the client in the submission of a New Drug Application 505(b)(2) to the FDA in a compliant manner. Download the proven case.