Validant Case Study

Confirming Application Integrity


A client was required by the FDA to have an independent third party verify that the analytical data used to support their filing ranges were authentic and tied to submissions and production batch records. They chose Validant to provide the review.


Validant resourced a multi-national team of 35 reviewers to:

  • Develop a robust review protocol
  • Perform on-site review of 48 products at the client’s site in India in four months
  • Coordinate the review in concert with legal counsel

Working within the required timeframe, Validant:

  • Delivered summary reports to the FDA on time.
  • Received acceptance of the report from the FDA, which is now in the process of final inspections to resolve the client’s Warning Letter and Import Detention.

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