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You can Rely on Reg-E-Stration LLC for cost effective compliance with FDA's Electronic Establishment Registration & Drug Listing requirements.
Reg-E-Stration LLC was founded in 2009 to meet the FDA's electronic establishment registration and drug listing challenge. We provide a complete service for human and animal pharmaceutical products, medical device site registration and device listing, as well as cosmetics and homeopathic product listing.
Reg-E-Stration LLC simplifies the process, because we have the expertise and experience to make this a quick and painless procedure. We were one of the 1st companies started in 2009 dedicated to assisting industry with FDA's eDRLS registration and drug listing requirements.
Reg-E-Stration makes things easy. All you have to do is provide us with some basic information about your company or products and we do the rest!
What sets us apart? We really KNOW how the FDA works. Our principal has over 20 years employment with the U.S. FDA as an Engineer, Compliance Officer, Investigator, and ran the Small Business Assistance Office in the Dallas FDA Regional Office. He has also held management positions in both the medical device and pharma industries for 20 years.
Our team of Associates capabilities encompass virtually every aspect of developing and implementing cost effective FDA compliance solutions. Reg-E-Stration LLC has the people, the background, knowledge, and experience to solve any FDA registration or drug listing issue you may have.
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New OTC Monograph Drug Facility User Fees (OMUFA) Published by U.S. FDA; Fees Due By February 11, 2021CFR LinkCFR Link
The U.S. Food and Drug Administration (FDA) Registration Renewal period is October 1 to December 31 each year. If you do not register or renew your establishment registration by the deadline, you will be in violation of FDA regulations. Contact Info@Reg-E-Stration.com
now to Register your site.
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News, Information and Resources for the U.S. FDA Regulated industries.