• Have you recently received a warning letter from a regulatory agency such as the U.S. FDA?
• Have you recently received a FDA 483 list of observations?
• Are you concerned you might receive one in the near future?

In the recent regulatory environment a large number of pharmaceutical and biotechnology companies have been recipients of one or more FDA 483 observations and Warning Letters. Light Pharma has developed a large database of the underlying characteristics of the letters and observations. Using our PHARMA INVESTIGATOR™ framework and our vast experience in the details of pharmaceutical manufacturing, batch record analysis and investigations we can provide you invaluable help to quickly understand:

• How your letter or observations compare with others in our database.
• 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