Welcome to Compliance Consultants...

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

We start early. Most regulatory professionals are not qualified to start until you "finish" building the prototype so they may appraise what you have done. Most "regulatory affairs consultants" do not file the application until the product changes are frozen. We start long before that. We typically start with the proof of concept and guide the process to conclusion. We shape the design, draft a preliminary plan for the regulatory strategy and assist in maturing the design from the earliest interval.

Bring us on board at the proof of concept level. Everything goes smoother, the sooner we start. We spent several days with your management and technical people to accumulate background and the required technical data. We sign a Confidential/Proprietary Disclosure Agreement to protect your intellectual property. We start by creating performance specifications and drafting test plans. The engineering process is independent and almost unrelated to the initial scientific / invention process. You will discover that the progress of your development is not based on the speed in which you develop ideas. The true progress is based upon the speed in which you develop meaningful test data and build irrefutable facts that validate your device in its environment.

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