Periodic Listings and PADERs

Periodic adverse drug experience report (PADER) listings are mandatory to be submitted as per stipulated timelines to US FDA.

For a large pharma company or a service provider, it is indeed a challenge to stick to these timelines with current resources in the aggregate team. This not only may lead to missing the deadlines, improper review of data submitted but also may lead to erroneous listings being submitted owing to piles of documents due for periodic submission.

PvEdge provides automated PADER listings to catch up with growing requirements of the industry and the periodic listings for a huge number of medicinal products.


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