Welcome to Compliance Consultants...

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

How we are different! The following are areas where we are clearly different from most every regulatory affairs professional in the business. You determine how valuable this distinction applies to your effort.

Our background is different. Most regulatory professionals have a legal, audit, manufacturing or quality Background. This is simply not the skill set necessary to work in a development arena. They work with the product after it is "born". We are development engineers. We start at inception. We discovered that is the most effective interval. Our process is more efficient and fewer design reversals occur.

The manner in which we charge is rare. Most regulatory affairs consultants work on an hourly rate. They learn on your "nickel". We already know how to submit the application so we charge on a fixed fee.

Most regulatory affairs consultants do not participate in the engineering development process. PLEASE ask them. Most regulatory affairs consultants stay far from your actual technology. They work by remote control. We "get dirty". We involve ourselves with every applicable facet to speed your approval. We attend your design reviews. We input into your design. We review your documentation. We look at your test procedures and test reports. We review or create your risk analysis.

We start much earlier than other consultants. Most regulatory affairs consultants will explain that they cannot file until the "prototype is frozen". They point to this as being an FDA "requirement". It is NOT. The 501(K) process is designed to apply to prototypes.

We create documentation. In most cases, few innovators have established engineering department able to create every document necessary to pass FDA. These are documents such as: requirements specifications, test plans, production documents, risk analysis, etc. We have made these on many occasions. You can retain us to create valuable, useful engineering documents. Since we have made so any, we are SURE our documents will go through the FDA review process without incident.

We answer the FDA questions for you. This is a significant benefit. Most regulatory consultants simply move the paper you write. We participate. We usually create a draft response to all questions from the FDA where you add the technical facts or analysis. We are skilled at truncating your risks to the questions so additional technical liabilities are not incurred. If you consider this trivial, just wait until you reach that point.

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