An American pharmaceutical company was looking for a Regulatory partner for authoring and finalizing the Periodic Adverse Drug Experience Reports (PADERs) for marketed drugs in the USA. The client had limitations in terms of insufficient information, which created various complexities in reviewing and providing compliant PADER reports.
Find out how Freyr meticulously streamlined the review process in accordance with the US FDA requirements and successfully delivered the reports in specified timelines. Download the proven case.
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