The client was an American multinational giant that was required to file original and LCM submissions for the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), while essentially wanting to focus on both speed and quality. This involves having a deep understanding of each agency's specific requirements and regulations, as well as the ability to adapt content effectively for local markets. Freyr’s talent pool was able to make timely submissions with zero warnings and carried out all the submission activities successfully.
Explore how Freyr successfully submitted valid original and LCM applications to the USFDA and EMA for a client, providing comprehensive support throughout the submission process. Access the detailed case study for further insights.
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