The customer is a global pharmaceutical company and was looking for Regulatory support in filing MAA original submissions to the USFDA and EMA. The project came with multiple challenges, such as stringent timelines, tracking versions of frequently changed and voluminous documents, and granular Document Level Publishing (DLP). Freyr’s talent pool created a tracker to check all the changes in the documents and validated them using Agency-recommended tools. Freyr delivered the MAA original submissions within the timelines, with zero errors and warnings.

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