A global leader in discovering, acquiring, developing, and commercializing biotechnological products based in Bermuda needed end-to-end local labeling support for a New Drug Application (NDA). The client realized that they required proven Regulatory assistance to overcome the format and content-related issues. They decided to partner with Freyr after conducting an extensive market evaluation. Freyr supported the client in preparing country labeling documents from initial validating of FPI and PI, the recreation of new electronic files until making recommendations based on format and content as per the PLR/PLLR standards.
Learn how Freyr enabled the client to prepare Regulatory compliant documents for their country-specific labeling needs through optimizing the existing labeling processes.