Welcome to Compliance Consultants...

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

We say NO to the FDA! On occasion this must/should be done. This should never be done irresponsibly. This should never be done in substitute for effort or investigation. But, the FDA does "over step" their authority. A federal judge did say several years ago that in a final ruling from a HIMA lawsuit that, "the FDA over estimates their position in the universe". It is not uncommon for a reviewer to require information, a test or compliance to a requirement that is simply NOT required. Most people with less experience than us are not confidant in their own knowledge. We are confident. We know when it is time to so NO and we have done so.

Many "regulatory affairs professionals" are reluctant to disagree or refuse the FDA. They do not want to infuriate their colleagues, the "regulatory affairs community or the FDA. You may suffer from this position.

We always approach the FDA with humility, with hat in hand. We understand how not to annoy them. But, we do authentically understand how to step aside, reverse, appeal, persuade FDA reviewers that their request sometimes is not applicable. We do so to achieve a savings or advantage for you. We fight for you when it is appropriate.

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