Martin M.
Comunication with company is perfect
Comunication with company is perfect. I am from Czech and everything was without problem. Martin Mach

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
Showing 90 reviews with 5 stars · Clear filters
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.
Len P.
They were a great help to us in getting our FDA labeler code and drug listings completed. That SPL language stuff was not something we wanted to get involved in at this time as a small company. Looking forward to working with them again if needed and for the renewals,
Julie
Fast and efficient
Jaime
The speed, efficiency, and quality of work provided were excellent, and the prices are very reasonable. The agent was extremely helpful and patient, answering all of my questions (of which there were many), in a very timely and coherent manner.
Stephen Krauss, Ph.D., C.
We could not be more happy with the service and the expertise supplied to us by FDA Basics. Working with our representative, Rush, was like having an exceptional "partner" in our business. We will definitely be using this fantastic company again and again in the future.
Daniel B.
Pragmatic handle my medical device registration In a very quick and professional manner, They answered all question promptly and made the whole process seamless, I would not hesitate to recommend them to anyone. 5 STARS!!
Chris
It was a pleasure to work with this group. Very professional and highly knowledgeable...