In March 2005, the Food and Drug Administration (FDA) issued guidance to the industry on the development, implementation, and evaluation of risk minimization action plans (RiskMAPs) for prescription drug products.  Although the guidance is only a few years old, we have been working on products requiring RiskMAP tools and systems since 1999.

• We have experience with six products that have required RiskMAPs

• Currently, we have two RiskMAPs in different stages of development—one has already been submitted to FDA for review and the second is being prepared for submission

• The head of our Team was responsible for RiskMAP services while working on the manufacture side of the pharmaceutical industry

• We have established strategic partnerships, so that we can offer a
  “one-stop” solution to a full range of Risk Management Services

As Risk Management continues to evolve, our experience and ongoing program development keeps us at the forefront of industry best practices.
For additional information, the FDA RiskMAP Guidance is available at:  http://www.fda.gov/cder/Guidance/6358fnl.htm