Karen C.
quick and supportive service
quick and supportive service

FDAbasics has helped companies in 100+ countries navigate U.S. FDA regulations since 1995. Based in Brooklyn, NY, we provide FDA registration, U.S. Agent representation, and compliance support across food, drug, medical device, and cosmetics industries. Our services include Food Facility Registration and FSVP Agent representation, Drug Establishment Registration and Listing, Medical Device Registration with free Device Listing, Cosmetic registration under MoCRA, U.S. Agent services for foreign establishments, and 510(k), eCTD, and DMF support. Clients choose us for our 30 years of FDA expertise, two-business-day turnaround, Certificate of Registration included at no extra charge, transparent flat-fee pricing, and direct access to senior consultants rather than call-center agents. From small family-run food exporters to global pharmaceutical manufacturers, we deliver accurate filings, responsive support, and honest guidance with clear communication and no jargon. Visit fdabasics.com or call 1-716-775-0533 to get started.
FDAbasics (fdabasics.com) has 97 customer reviews on Five Star Index, with an average rating of 4.9 out of 5.
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Administration & Services · New York, New York
Excellent

Administration & Services · New York, New York
Excellent

Administration & Services · New York, New York
Excellent

Administration & Services · New York, New York
Excellent
97 approved reviews, newest moderated first
Karen C.
quick and supportive service
Daina
Value for money and reliable
Anamaria
Good experience
Tony S.
Very quick and helpful staff
Vinay P.
Excellent co-operation. Timely response received.
Astrid R.
Very satisfied with the service
Martin M.
Comunication with company is perfect. I am from Czech and everything was without problem. Martin Mach
Tony
Easy to work with, navigated the maze of regulatory steps to get our facility registered with the FDA and self identified with GDUFA. Simplified the process enormously.