| Countries Served | 135+ countries across every continent |
| Coverage Model | U.S.-based team; registrations handled remotely, wherever you are |
| Who We Serve | Foreign manufacturers, U.S. Importers of Record, brand owners, distributors & logistics partners |
| Core Services | FDA registration, U.S. Agent, FSVP agent, Prior Notice, labeling, renewals |
| U.S. Agent Requirement | Mandatory for every foreign facility — we serve as your FDA point of contact |
| Typical Turnaround | Many registrations confirmed within 24–48 hours once information is complete |
| Government Fees | No FDA fee for food-facility registration; we quote transparent flat service pricing |
| Track Record | 1,000+ companies, 15+ years of combined FDA regulatory experience |
FDA Registration Works the Same, No Matter Where You Are
FDA requirements are triggered by the product and its entry into U.S. commerce — not by your country. A food, drug, device, or cosmetic facility shipping to the United States generally must register with the FDA regardless of location, and every foreign facility must appoint a U.S. Agent. What differs by country is the local regulator you answer to at home, which is separate from the FDA. We bridge both.
1. Tell Us Where You Are & What You Ship
Send your facility location, product type, and target U.S. entry. Location never changes whether FDA registration is required — only how we route it.
2. We Map Your FDA Requirements
We identify the registrations, listings, U.S. Agent, FSVP, and labeling that apply to your specific products and market.
3. We File & Act as Your U.S. Agent
We prepare and submit your FDA registrations accurately and serve as your mandatory U.S. point of contact with the agency.
4. We Keep You Compliant
We track biennial and annual renewals, respond to FDA communications, and support you through import alerts and updates.
Everything You Need to Reach the U.S. Market
Every service below is delivered remotely to clients in any country we serve, using U.S. FDA systems and our U.S.-based team as your point of contact.
Foreign & Domestic Facility Registration
FDA facility registration for food, drug, device, and cosmetic establishments — whether your plant is overseas or in the U.S.
FDA U.S. Agent Services
We act as your mandatory U.S. point of contact with the FDA — required for every foreign registered facility.
FSVP Agent & Plan Development
Foreign Supplier Verification Program agent representation and plan preparation for U.S. food importers.
FDA Prior Notice
Prior Notice filing for FDA-regulated shipments so your goods clear U.S. entry without avoidable holds.
Cosmetic Registration (MoCRA)
Facility registration and product listing for cosmetics and personal-care goods under the MoCRA law.
Drug & Device Listing
Drug establishment registration, NDC and device listing, and annual renewal management for regulated makers.
FDA Label & Claims Review
Review of labels, ingredients, and claims against FDA rules before your product reaches the border.
Renewals & Ongoing Compliance
Biennial and annual renewal tracking, import-alert response, and long-term regulatory support.
For official U.S. import requirements, see the FDA's guide to importing FDA-regulated products.
Built for Exporters, Importers & Brand Owners
Foreign Manufacturers & Exporters
If your products are made overseas and shipped into the United States, FDA registration and a U.S. Agent are typically required. We handle both remotely so you never need a U.S. office.
U.S. importers of record
For many imported foods, the importer must run an FSVP. We serve as FSVP agent and build the plans that keep your entries moving.
Brand Owners & Private Label
Selling an imported product under your own brand? We make sure the facilities behind it are registered and your labels meet FDA rules.
Distributors & Logistics Partners
We coordinate registrations, Prior Notice, and U.S. Agent duties across suppliers and ports so shipments clear without avoidable holds.
FDA Registration Service Areas by Country & City
Browse our FDA registration and U.S. Agent service areas. Select your country for a dedicated page covering the national regulator, export sectors, and how U.S. FDA requirements apply, or jump straight to your city or port of export. We support 180+ countries and 451+ cities and ports worldwide.
United States of America
International
Service Areas — Frequently Asked Questions
What areas does FDA Registration Assistance serve?
We serve companies worldwide. Our team is based in Miami, Florida and has helped over 1,000 companies across 135+ countries. We support foreign manufacturers exporting to the United States as well as U.S. importers, brand owners, and distributors, and we cover major U.S. cities, ports of entry, and import hubs. Because FDA registration is handled electronically with the U.S. FDA, we complete it remotely regardless of where your facility is located.
Do you only work with companies based in the United States?
No. Most of the companies we serve are foreign manufacturers and exporters shipping FDA-regulated products into the U.S. market. Foreign facilities have specific obligations, including the requirement to appoint a U.S. Agent, and we handle those requirements alongside U.S.-based clients.
Can you help my company if we are located outside the United States?
Yes. Serving foreign facilities is our core focus. We register your establishment with the FDA, serve as your U.S. Agent, prepare FSVP and labeling where required, and manage renewals, all remotely from the United States. You do not need to travel or open a U.S. office.
Does my country change whether I need FDA registration?
No. FDA requirements are triggered by the product and the fact that it is entering U.S. commerce, not by which country you are in. A food, drug, device, or cosmetic facility shipping to the U.S. generally must register regardless of location. What can differ by country is the local regulator you also answer to at home, which is separate from the FDA.
Do you need a physical office in my country to help me?
No. FDA registration, U.S. Agent representation, and FSVP are all handled through U.S. FDA systems and U.S.-based processes. We work with clients in 135+ countries without a local office by managing everything electronically and acting as your point of contact in the United States.
How can a U.S.-based firm handle my FDA registration remotely?
FDA facility registration and product listing are electronic filings made with the FDA in the United States. We collect your facility and product information, prepare the filings correctly, submit them, and serve as your U.S. Agent. Nothing requires an in-person visit to your country, which is why remote service works for exporters anywhere in the world.
What is a U.S. Agent and why do foreign facilities need one?
A U.S. Agent is a person or company located in the United States that acts as the official point of contact between the FDA and a foreign facility. The FDA may contact the U.S. Agent about inspections, regulatory questions, or emergencies. Foreign establishments must designate a U.S. Agent during FDA registration, and without a valid one the registration cannot be completed.
Do all foreign facilities need a U.S. Agent?
Foreign facilities that register with the FDA, including food, drug, and medical device establishments and certain cosmetic facilities, are required to designate a U.S. Agent. We provide dedicated, responsive U.S. Agent services for clients in every country we serve.
Which countries do you serve?
We serve 135+ countries across the Americas, Europe, the Middle East, Africa, Asia, and Oceania. Our directory on this page links to dedicated service-area pages for individual countries and their key cities and ports. If you do not see your country listed, contact us, as our coverage continues to expand.
Do you serve companies in sanctioned or embargoed countries?
U.S. FDA requirements are separate from U.S. sanctions law. Trade with certain countries or parties is restricted or prohibited under U.S. sanctions administered by OFAC, and those rules apply regardless of FDA registration. Where a country or transaction is subject to comprehensive sanctions, we cannot facilitate prohibited trade. Contact us with your specifics and we will explain what is and is not permitted.
What FDA-regulated products do you help register?
We cover food and beverages, dietary supplements, cosmetics and personal-care products under MoCRA, drugs and pharmaceuticals, and medical devices. Each category has its own registration, listing, and labeling pathway, and we map the correct one for your products no matter where you are based.
Is FDA registration the same in every country we serve?
The FDA requirements themselves are the same because they are U.S. federal rules, so a facility in one country faces the same core obligations as a facility in another when shipping the same product to the U.S. What varies is your home-country regulator and export process, which is why our country pages explain how local systems interact with the FDA.
How quickly can you complete FDA registration regardless of location?
Many registrations, such as food facility registration and U.S. Agent setup, can be completed within 24 to 48 hours once all required information is provided. Timelines are driven by how quickly complete and accurate information is available, not by your country.
Do you provide FSVP agent services for importers?
Yes. For many imported foods, the U.S. importer of record must operate a Foreign Supplier Verification Program. We act as FSVP agent and develop FSVP plans so importers meet their verification obligations and reduce the risk of entry problems.
What information do you need to start, and does it differ by country?
We typically need your facility details, product categories, and intended U.S. entry information. The core information is the same worldwide; the difference by country is usually the supporting export documentation your local authorities issue. We tell you exactly what applies to your situation before we begin.
Do you help with U.S. ports of entry and import logistics?
Yes. We support clients shipping through ocean container ports, air cargo gateways, inland hubs, and land-border ports of entry across the United States. Our focus is getting the required FDA registrations and, where applicable, FSVP in place before your shipment arrives so it is not delayed, held, or refused.
Can you serve as our U.S. Agent if we already have an FDA registration?
Yes. You can update your U.S. Agent with the FDA at any time. If your current agent is unresponsive or you need more reliable representation, we can take over as your U.S. Agent and manage FDA communications going forward.
Do you charge different fees depending on the country?
Our pricing is based on the services you need, not on your location, and we quote transparent flat pricing before starting. Note that the FDA does not charge a fee for food facility registration itself; some other FDA programs carry government fees, which we explain up front.
Does FDA registration mean my product is FDA-approved?
No. Registration and product listing are regulatory requirements and do not represent FDA approval or endorsement. This is true for every country we serve. We make sure your registrations and listings are accurate so your products can enter U.S. commerce as required.
What happens if my registration lapses while operating overseas?
A lapsed registration can trigger import detentions, border holds, and shipment refusals. Food facilities renew biennially during the October 1 to December 31 window in even-numbered years, and drug and device establishments update annually. We track these deadlines for clients in every country so registrations stay active.
Do you support companies with multiple facilities in different countries?
Yes. We regularly manage FDA registration, U.S. Agent representation, and renewals for groups with several plants across multiple countries, keeping all establishments consistent and compliant under one point of contact.
Which U.S. cities and ports do you support?
We support businesses across major U.S. cities and ports of entry, including Miami, New York, Los Angeles and Long Beach, Houston, Savannah, Seattle and Tacoma, Newark, Charleston, Baltimore, New Orleans, and many more. Our directory lists our U.S. service areas alongside our international coverage.
Can you help with FDA label and ingredient compliance for imported products?
Yes. We review labels, ingredients, and claims against FDA requirements before your products reach the border. Correct labeling is a common cause of entry problems, so we address it as part of getting your goods cleared for the U.S. market.
Do you offer support in languages other than English?
We work with exporters worldwide and routinely support non-English-speaking clients through the FDA process. Contact us about your language needs and we will make sure requirements and next steps are communicated clearly.
How do I get started from my country?
Contact FDA Registration Assistance with your facility location and product type. We will confirm which FDA registrations, U.S. Agent, FSVP, and labeling steps apply and provide a clear, flat-fee quote. Most clients can move from first contact to submitted registration within a few business days.
Wherever You Are, We Handle Your FDA Compliance
Tell us your facility location and product type. We will confirm which FDA registrations, U.S. Agent, FSVP, and labeling steps apply and provide a clear, flat-fee quote — typically within 24 hours.
