Our FDA Compliance Services

FDAbasics is a US FDA consulting firm headquartered in Brooklyn, New York, with over 30 years of experience helping foreign manufacturers comply with US FDA requirements. We serve clients from more than 100 countries across four regulated industries: food and dietary supplements, medical devices, drugs, and cosmetics. Our services cover everything a foreign manufacturer needs to legally market products in the United States, including FDA registration, US Agent appointment, product listing, labeling review, and complex regulatory submissions. We are 5-star rated on both Trustpilot and Google for fast turnaround, responsive communication, and deep regulatory expertise. Transparent fees, no hidden costs, and a single point of contact for all your FDA compliance needs.

Every foreign company selling food, drugs, medical devices, or cosmetics in the United States is required by law to appoint a US FDA Agent, a US-based representative who serves as your official point of contact with the FDA. Your US Agent receives regulatory communications, assists with inspections, and keeps your registrations current. The right agent protects your ability to import. The wrong one, or none at all, can bring your shipments to a halt. FDAbasics has served as the trusted US FDA Agent for foreign manufacturers across more than 100+ countries for over 30 years. We are headquartered in Brooklyn, New York, respond promptly, and charge transparent fees with no hidden costs.

Foreign food and dietary supplement manufacturers must register their facility with the FDA and appoint a US FDA Agent before their first shipment enters the United States. Registration must be renewed every two years, and missing the December 31 deadline means your products are detained at the border. FDAbasics handles every step: facility registration, US Agent appointment, Prior Notice filing, FSVP compliance, and food label review. There are no government fees for food facility registration, and with FDAbasics as your US Agent, registration assistance is included at no extra charge. Fast turnaround, clear communication, and 5-star ratings on Trustpilot and Google.

Foreign medical device manufacturers must register their establishment with the FDA every year, list every device they distribute in the US, and appoint a US FDA Agent. Depending on your device classification, a 510(k) clearance or Premarket Approval may also be required before your device can legally enter the US market. FDAbasics helps Class I foreign medical device manufacturers navigate establishment registration, device listing, and US Agent appointment, with device listing included at no additional charge and no fees for adding proprietary names. With over 30 years of regulatory experience and the most competitive fees in the industry, we make FDA compliance straightforward so you can focus on your business.

Foreign drug manufacturers, including OTC, prescription, generic, and API producers, must register their establishment with the FDA annually, obtain an NDC Labeler Code, list every drug product, and appoint a US FDA Agent before marketing any drug in the United States. For generic drug manufacturers, annual GDUFA facility fees are also required and paid directly to the FDA. FDAbasics supports foreign drug manufacturers through every stage of FDA compliance: establishment registration, NDC numbers and drug listing, GDUFA self-identification, Drug Master File (DMF) filing in eCTD format, and other services related to ANDA, IND, and NDA applications. One trusted partner for everything your drug business needs to operate in the US.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) changed everything for foreign cosmetic manufacturers. If you distribute cosmetics in the United States, you are now required to register your facility with the FDA, appoint a US FDA Agent, and submit a product listing for every product you sell. The good news is that there are no government fees for MoCRA registration or product listing, making this one of the most accessible FDA compliance requirements. FDAbasics guides foreign cosmetic manufacturers through MoCRA facility registration, FEI number setup, product listing submission and annual updates, and cosmetic label review, all in one place, at transparent fees, with the experience to do it right the first time.

Send us a message and we'll reply back within one business day. You'll always speak with a real person on our team. We're looking forward to becoming your FDA compliance partner.

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