The client was an American specialty pharmaceutical company that was required to file ANDA-LCM and pre-IND Submissions for the US Food and Drug Administration (FDA) and was looking for quality submissions to be delivered in brief timelines. 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.
Discover how Freyr's expertise enabled timely ANDA-LCM and pre-IND submissions for an American pharmaceutical company with specialty products, meeting stringent FDA requirements while ensuring quality outcomes within tight timelines. Zero warnings underscored our commitment to excellence.
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