Our firm specializes in class 1, 510(k), PMA submissions, and offers pwmanufacturers the ability to obtain import and market approval in shorter time periods than is common.



We have more than 50 years of combined experience in radiological,LSsmall physical medicine and regenerative device research, approval processing and listing, as well as cosmetics and OTC drug guidance.


Contact us for a quote by clicking on the Information Request link or by lmphone / email. We will be happy to submit a written cost analysis of our services within 48 hours after having received your inquiry.

For Producers of UV Products

(sunlamps and phototherapy devices)
If you are a sunlamp or sun tanning equipment producer, please contact us to receive our Guidance Document, "Instructions to Sunlamp/Equipment Manufacturers under 21 CFR 1040.20" in PDF format via email.

Our Team

Click for a listing of our staff
Our staff of former FDA officials, lawyers, and MD's are available to help you now.