Welcome to Compliance Consultants...

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

 

compare us to some of the largest regulatory affairs consultants in the U.S. We have been selected (based on technical merit and qualifications ) over some of the "most notable" regulatory consulting firms in America. Those firms had big offices filled with former FDA reviewers. They could review but not create clinical studies or technical directions for device development, testing and documentation. If you doubt it, ask for a regulatory submission plan to support your product development. Ask them if they are so certain, they will commit to a fixed fee cost. We do!


A team of three German Ph.D's. spent six months to select a regulatory consultant for a critical new project. These scientists identified and came to the U.S. to visit the largest U.S. regulatory consulting firms to choose the best firm for a new, difficult scientific medical device project. A colleague of theirs who knew of Compliance Consultants recommended that we be included in this search. When we met with this team, we advised that during the course of their interviews (regardless of the reputation of the organization or size of the office building) the team should ask the consulting companies to produce the specific individual, shake their hand and interview the professional who would actually accomplish the project. After three months of visits, meetings, telephone interviews, these Ph.D.s' choose Compliance Consultants "hands down". They returned with a resounding affirmation of our instincts, none of these firms were able to draft a technical plan or create a strategy that compared to ours. The regulatory affairs professionals interviewed at "large regulatory affairs organizations" were "Quality Assurance Engineers" from manufacturing NOT R & D (development) engineers from the research world as we are from. This client finally realized the distinction and difference between QA and R&D engineers. Refer to "How we are different"..




We were also the "cheapest". Our cost was under ˝ of the largest firm. Refer to "How we charge"..We explain it this way. If a roofer had done 100 roofs in your town, should he be able to climb on top of your roof and give you a fixed fee estimate based on common guidelines? Well, we have done so many, we can give you such an estimate and deliver as promised. Most all large regulatory affairs organizations are not certain of the project so they indemnify them selves by having you assume the risk of what they do not know. We know what we must and can sign up to a specific project for a specific fee.

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 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.

 

            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.

 

            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.

 

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

 

Large FDA Consulting firms staff up to support large companies who have traditional submissions. We focus on small start up, high technology, innovative companies.

 

You will discover (after research) that a large “regulatory affairs organization” will:

            charge more money;

            not file as soon as we will file;

            not define the filing point in product development as early as we do;

            probably “give-in to having ” clinical trials,

            will not defend you as to not affect their reputation with the FDA,

            not be as technically qualified as we are;

            not send you a professional as qualified as we will send you;

            not have the same intensive, focus or attention as we will;

            not achieve a determination of S.E. as quickly as we will.

 

We have purposely not focused on increasing the size of our organization. Our engineering depth is not easily replicated. You will not find in any organization with engineers with more medical product development experience. One of our engineers having managed design over 35 engineers in over 100 medical devices for an eight year period at Raytheon Medical Imaging, joined Compliance Consultants. Since then, he has worked on many 35 complex devices.

 

 

Most of our clients are innovative start up companies who have radical new products. We have successfully avoided having to file many devices as Class III (PMA submissions) classifications and have been successful in achieving a determination of S.E. for many Class II submission - even some submissions had been rejected by the FDA.

 

If you investigate, you will discover that many large firms (three in the Rockville/D.C. area, one in Boston) routinely use experts such ourselves to submit their difficult non traditional submissions.



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



home back listing

  Compliance Consultants
1151 Hope Street
Stamford CT 06907 USA
voice 203 329 2700
fax 203 329 2345