Your Trusted FDA Compliance Partner Since 1995
US Agent, FDA registration, and full compliance support for food, drug, medical device, and cosmetic companies worldwide. We take care of the regulatory details so you can focus on getting your products to market.
★★★★★
5-star rated on Google
Verified client reviews
📍
Brooklyn, NY
US-based team
✓
Certificate of Registration
Included with every registration
$
Transparent fees
Published on every page
Verify a certificate
Buyers, importers, and customs brokers: enter the Control Number printed on an FDAbasics Certificate of Registration.
Printed at the bottom of the certificate, beside the QR code.
Everything You Need to Comply with the FDA — Under One Roof
FDAbasics is a full-service FDA compliance firm. Whether you are registering for the first time, renewing an existing registration, or navigating a complex submission, we handle the entire process. US Agent appointment, facility registration, product listing, labeling review, and regulatory submissions — all from a single trusted partner.
All Industries Learn More About US Agent →
US FDA Agent Services for Foreign Companies
Official US Agent designation across all four industries
Receipt and forwarding of all FDA communications
Inspection scheduling assistance
Registration, renewal, and compliance deadline management
US business hours availability — real team, not a virtual office
Mandatory
Required by FDA for all foreign food, drug, device, and cosmetic companies
30+ yrs
FDAbasics has served as US Agent since 1995
100+
Countries where our US Agent clients are located
$250/yr
US Agent fee on a 2-year contract — fees published, no surprises
Food & Dietary Supplements Learn More About Food →
FDA Food Facility Registration and Compliance
Foreign and domestic food facility registration
US Agent appointment and biennial renewal
FSVP compliance and agent services
Prior Notice filing for food shipments
FDA food label compliance review
FCE and SID registration for low-acid canned foods
$0
Government fee for food facility registration
2 yrs
Biennial renewal — Oct 1 to Dec 31 of even-numbered years
2 days
Registration turnaround with Certificate of Registration included
FSVP
Required for US importers under 21 CFR Part 1, Subpart L
Drugs & Pharmaceuticals Learn More About Drugs →
FDA Drug Establishment Registration and Compliance
Drug establishment registration and annual renewal
NDC Labeler Code and drug product listing
GDUFA self-identification
Drug Master File (DMF) filing in eCTD format
ANDA, IND, and NDA application assistance
No changes certification for product listing
Annual
Drug establishment registration renewed every year Oct 1 to Dec 31
GDUFA
Generic drug manufacturers must self-identify and pay FDA facility fees annually
eCTD
Mandatory electronic format for all FDA drug regulatory submissions
4 days
Drug establishment registration turnaround at FDAbasics
Medical Devices Learn More About Medical Devices →
FDA Medical Device Registration and Compliance
Medical device establishment registration and annual renewal
Device listing — included at no extra charge
UDI / GUDID submission assistance
510(k) US Agent services
FEI number assistance
US Agent change support at no additional fee
Annual
Medical device establishment registration renewed every year Oct 1 to Dec 31
FDA fee
Annual establishment registration fee required — paid directly to the FDA
Class I–III
Device classification determines 510(k), PMA, or De Novo pathway requirements
Included
Device listing included at no extra charge with registration
Cosmetics (MoCRA) Learn More About Cosmetics →
FDA Cosmetic Registration and MoCRA Compliance
MoCRA facility registration and biennial renewal
Cosmetic product listing and annual renewal
US Agent appointment for foreign cosmetic companies
FEI number request for cosmetic facilities
Cosmetic label compliance review
MoCRA exemption analysis — confirm if registration is required
MoCRA
New law — mandatory FDA registration for cosmetic manufacturers since 2022
2 yrs
Facility registration renewed biennially — product listing renewed annually
Foreign
Foreign cosmetic companies must appoint a US Agent under MoCRA
Exempt?
Small business exemptions may apply — contact us to confirm your status
30+
Years serving foreign manufacturers
100+
Countries where our clients operate
2
Business days to registration completion
4
FDA-regulated industries covered
30 years of client trust, built one registration at a time
Here's what our clients rely on us for.
Full-service
One partner for everything
Food, drug, medical device, and cosmetics — all under one roof. No need to manage multiple compliance vendors across different FDA-regulated categories.
Transparent
Fees published on every page
No hourly rates, no hidden charges. You know exactly what you are paying before you start.
Fast
Registration in 2 business days
Your registration number and Certificate of Registration delivered in 2 business days. Ready for buyers, importers, and customs brokers.
Trusted
5-star rated by clients worldwide
Rated 5 stars on both Trustpilot and Google by verified clients across 100+ countries. Read our reviews before you decide.
US-based
Real team in Brooklyn, NY
Physically located in the US, meeting all FDA requirements for US Agent services. Reachable during US business hours — not a PO box or virtual office.
Experienced
30+ years of regulatory depth
Deep knowledge across all four FDA-regulated industries. We have seen every scenario and know how to navigate them.