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Regulatory Compliance : Compliance Assessment

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It seems all the average fellow needs to make him take a chance is a warning. -- Kin Hubbard, Abe Martin on Things in General

  • Have you recently recalled a product or received a warning letter from a regulatory agency?
  • Have you recently received a FDA 483 list of observations?
  • Are you concerned about this happening in the near future?

In the recent regulatory environment a large number of life sciences companies have been recipients of one or more FDA 483 observations and Warning Letters. We have developed a large database of the underlying characteristics of the letters and observations. Using our PI™ framework and our vast experience in the details of life sciences operations, batch record analysis and investigations we can provide you invaluable help to quickly understand:

  • How your recalls, letter or observations compare with others
  • Potential Underlying Causes of Such Observations
  • Common Aspects of Many of the Recent Regulatory Observations
  • Severity of a Particular Letter or Observation Compared to Others in the Past
  • Categorization of Regulatory Observations into Their Components
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