Welcome to Compliance Consultants...

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

Do you need an attorney, a QC Inspector or a regulatory engineer? Most of those newly initiated to regulatory demands immediately assume that an attorney would be the first choice for regulatory actions. As we all know attorney involve themselves in most areas of our lives. This is not one of those where they are effective. Even the FDA agrees. The Division of Small Manufacturers (do not let this fool you any company with under 5000 employees qualify) even publish that regulatory submissions are clear enough for the common man. There are virtually no legal issues, these are all subtle issues that require depth and detail analysis.

If you investigate, you will discover that many large firms (three in the Rockville/D.C. area, one in Boston) routinely use other experts (seasoned engineers, such ourselves to submit their difficult non traditional submissions). These organizations are the "front" people who pretend to be experts but have little true knowledge about regulatory design, project development and engineering documentation.

Large FDA Consulting firms may present the perception of expertise but will not have the regulatory excellence that we offer. You will not find any consultants (man for man) as qualified as we are. Most large consulting firms are composed of attorneys, former FDA reviewers, auditors, writers or production/QC people. These people cannot guide a development effort along the straight and narrow. We can.

Attorneys who do not understand product development or technology. They lack the ability to appraise your documentation and technical issues which the FDA may question. They simply lack the skills to create any actual submissions. They can only read FDA guidance documentations. They cannot direct you along the correct path with confidence. They simply do not have real experience in creating new products.

Former FDA employees who imply they have a special friend or operational visibility into the FDA (which is both erroneous and a breach of good science). The FDA rotates reviewers so influence virtually cannot exist. We have had FDA reviewers apply to us for jobs and as part of the interview, they admit their weakness is in creating an application. They are simply reviewers.We use the example of having an art critic paint on canvas. Just how good of a painter would an art critic be?

Former auditors in manufacturing who understand Good Manufacturing practices but - not product development. These professions will require from you more than what may be necessary since they cannot exercise the technical discretion that we can.

Technical Writers. These people understand text, prose, and writing skills. They also cannot apprise, review or assess the quality of your engineering.

Large FDA Consulting firms staff up to support large medical device companies who have traditional submissions. Their people are not as versatile as we are. We focus on small start up, high technology, and innovative companies.

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