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FDA Registration & U.S. Agent for Foreign Cosmetic, OTC, Supplement & Food Brands

U.S. manufacturers use the same team for MoCRA, listing, labeling, and cosmetovigilance.

Our Services

Services

I need a U.S. Agent

FDA requires every foreign establishment to name a U.S. Agent with a physical U.S. address. We are that point of contact for drug, device, cosmetic and dietary supplement registrations — receiving FDA correspondence, answering inspection and import questions, and staying reachable in U.S. business hours so a notice never sits unanswered.

U.S. FDA Agent for foreign manufacturers

I need food facility registration

Food facility registration and biennial renewal for foreign manufacturers shipping to the U.S., including U.S. Agent support when you need it.

My shipment is held by FDA

When FDA holds a shipment or sends a notice, speed and clear next steps matter. Tell us what you received and we will help you respond.

I sell supplements in the U.S.

Dietary supplements are regulated as food, with extra layers: facility registration, U.S. Agent when foreign, Supplement Facts and claims, and NDI paths when they apply. We map the registration and label steps for foreign makers.

I need OTC drug registration

Sunscreen and many personal-care actives are OTC drugs, not cosmetics. We help with establishment registration, listing and SPL, and Drug Facts label review.

I need MoCRA cosmetics help

MoCRA covers cosmetic facility registration, product listing, and serious adverse event reporting for many foreign brands. We help you map what applies to your formula and U.S. market plan.

Flat $249 per facility per year for food, dietary supplement and cosmetics facilities. OTC, API, pharma and device work is quoted by class.

Ready to Appoint Your U.S. Agent?

Connect with our regulatory experts to discuss FDA registration, dossier planning, or GMP compliance strategies. Let’s make your global submissions simpler and faster.

Contact

Have questions?

Chat with us , Email us , Use our contact form , Call us or simply explore our detailed FAQ section for clear answers on U.S. Agent responsibilities, FDA registration steps, drug listing, SPL requirements, FSVP rules, and more.

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