Regulatory Support in Lifecycle Management Submissions

The client is a US-based pharmaceutical company and was looking for Regulatory support in lifecycle management submissions for the USFDA. The project had several challenges in the form of tracking frequently changed documents, validating them with Agency-approved tools, and filing them in stringent timelines. Freyr’s team offered granular Document Level Publishing (DLP) and created a tracker to check the frequent changes. Freyr delivered the submissions on time.

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