They are very prompt , responds to emails within few minutes. They have all information for a prompt and immediate support. I would highly recommend FDA basics for all compliance needs. Mr Yash wa... Vis mer
Vi bekrefter ikke spesifikke uttalelser siden en forfatters mening er hens egen, men vi kan merke en anmeldelse som "bekreftet" når vi kan bekrefte at det har vært kontakt med virksomheten. Mer informasjon
For å beskytte plattformens integritet vil alle anmeldelser på plattformen—bekreftet eller ikke—bli undersøkt av vår automatiserte programvare (tilgjengelig hele døgnet). Denne teknologien er designet til å identifisere og fjerne innhold som bryter med retningslinjene våre, deriblant anmeldelser som ikke er basert på en faktisk erfaring. Vi vet at vi ikke kan fange opp alt. Hvis du tror at vi har gått glipp av noe, kan du rapportere det. Mer informasjon
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We had such a great experience working with Emily from FDAbasics. She was super helpful and really generous with her time, sharing a ton of valuable info with us even before we had committed to an... Vis mer
This company is so amazing and generous with their time. Emily assisted us in figuring out the best path forward for our application. She was so direct and easy to understand. I definitely recommend t... Vis mer
I thought we were in trouble when our shipment was held by FDA because the manufacturer was not properly registered. Rush and FDAbasics guided me through all the steps needed to obtain the proper reg... Vis mer
Informasjon om virksomheten
Skrevet av virksomheten
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.
Kontaktopplysninger
1 Prospect Park W Ste 4D, 11215, Brooklyn, USA
- +1-716-775-0533
- info@fdabasics.com
- fdabasics.com
To be honest this is the first time I …
To be honest this is the first time I use an agency.Before I did it on my own which I cannot do any more. Your agency were quick and precise with all the tools to make it happen
Great Experience.
Great Experience.
Would recommend, our lodgement was done super fast and customer service was very helpful with my many questions. Great prices too.
Pragmatic review
Pragmatic were very responsive and efficient throughout the registration process. Despite the time difference they responded as soon as possible and dealt with my queries rapidly.
quick response
quick response
flexible attitude
reasonable price

Svar fra FDAbasics
Professional and well priced.
I was very happy with Pragmatic's …
I was very happy with Pragmatic's service and would definitely recommend them! I had reached out to few other companies to get a quote on fees and turnaround time to assist our company and Pragmatic went over and above for us so it was a no brainer for us who we decided to move forward with. Very satisfied. Thank you!!
Very knowledgeable and helpful service
Very knowledgeable and helpful service. Accessible and quick to respond to questions or whenever an issue came up.
Rush at Pragmatic was an excellent …
Rush at Pragmatic was an excellent communicator. He was thorough, professional and as fast as his name indicates. I would highly recommend this company.
Great and instantaneous services all …
Great and instantaneous services all the times. I strongly recommend Pragmatic compliance for availing regulatory services.
P.V. Krishna Murty

Svar fra FDAbasics
Regulatory Consulting
I have had excellent service from Pragmatic Compliance. I would recommend this company for any regulatory consulting needs.

Svar fra FDAbasics
Perfect Service for FDA registration
Perfect Service for FDA GDUFA self identification and Establishment Registration for foreign Companies. Prompt and round the clock Response.
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