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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.

 

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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.

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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.