The client was a China-based biotechnology company that was looking for Regulatory support in LCM submissions for IND applications. The project presented challenges such as stringent timelines, tracking versions of frequently changed documents, and replacing them in the eCTD format. Freyr was able to make the submissions to the US FDA by reviewing all the documents and validating them using Agency-approved tools. With an expert talent pool, Freyr was able to file the submissions with zero errors and warnings.
Learn how Freyr addressed multiple challenges and delivered end-to-end Regulatory support to the client by reviewing the frequently changed documents and tracking all the version changes with a detailed tracker. Download the proven case.