AEGIS is a primary provider of United States Food and Drug Administration listing and consultation services for overseas and domestic producers of products regulated under Title 21 of the Code of Federal Regulations (CFR).

 

Our firm specializes in 510(k) / PMA submissions, and offers manufacturers the ability to obtain import and market approval in shorter time periods than is common. We also have over 20 years of experience in composing Initial, Model Change, and Annual Reports for UV-emitting devices, and provide both in-house and mobile NIST-calibrated spectral analyses. Our professional staff of technicians is ready to serve our clients' needs by traveling to their facilities with very little prior notice.

 

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