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Submission of post-approval changes to the FDA within the decided timeframes is challenging without prior experience and stringent Regulatory expertise. One of our leading pharmaceutical development clients approached Freyr with this business imperative.
With Freyr’s Regulatory Affairs and Operations team's support, which included internal reviews and necessary internal steps, the client received complete benefit and understanding in this regard.
Moreover, the client was apprised of the gaps identified, and total Regulatory support in the future was assured.
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