A global leader in innovating pathways for 505 B2 approvals based in the USA was looking for a Regulatory expert to develop USPI labeling documents for 505 B2 NDA approval. The client had various bottlenecks due to the absence of first-hand clinical and non-clinical data and outdated labeling content of the RLD. By performing the fast-track assessment with multiple level quality checks, Freyr enabled the client to achieve a first-time-right document that resulted in significant savings in terms of time and cost.

Learn how Freyr helped the client strengthen their labeling functions and ensured submission-ready documents while meeting the defined timelines.