Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

We repair your catastrophes

We sometimes inherit a failed or troubled project. One client can tell you that he had a version of a medical device rejected by the FDA - three years before we met. Later, we re-submitted the same design but designed the submission to obscure that deficiency. This new submission was "approved", the issue (that earlier had caused the rejection) was never challenged by the FDA. They now understand the value now of having an assortment of data and often data overkill in an area to obscure an issue that could be very volatile and outright cause for rejection.

copyright by Compliance Consultants, Stamford, CT USA, September 2001