Choosing an FDA registration provider from outside the United States usually means relying on what the provider says about itself. This article takes a different approach. It sets out six reasons foreign exporters choose FDABridge for FDA registration and U.S. Agent work, and for each one it points to the FDABridge page where you can check the point before you order. You will not find client numbers, ratings or testimonials here, because you cannot verify them from this page. What you can verify is how each service is scoped, priced and limited.
1. Food, cosmetics and drugs, plus EU services, from one provider
FDABridge's service menu is organized by FDA program. Food services include facility registration and renewal, DUNS support, shell egg producer registration, label review and Prior Notice, plus FCE/SID filings for low-acid canned and acidified foods. Cosmetics services include FEI support, MoCRA facility registration, product listing and label review, and adverse event management. Drug services cover establishment registration, NDC labeler codes and drug listing. The site also lists quote-based work for medical devices and radiation-emitting products.
For companies that also sell in Europe, FDABridge offers EU Responsible Person assignment and CPNP notification, with separate safety report, product information file, label, claims and testing services. Its REACH service covers assessment, dossier and data-access coordination, with Only Representative support through qualified EEA partners. US services are priced in US dollars and EU services in euros.
2. Published prices, with a quote where the scope varies
Per-service and bundle prices are published on the pricing page, so you can compare options before contacting anyone, and the pricing page keeps FDABridge's professional fees separate from FDA government fees. Where the work depends on the case, the scope is reviewed first. Drug establishment registration is marked ‘Quote reviewed before filing’, and drug services follow a review-first process so that pricing and scope are confirmed before payment is requested. A standalone U.S. Agent appointment or transfer is quoted after the product category and FDA record are checked.
3. Inclusions, exclusions and evidence, written down for each offer
The pricing page includes a scope comparison for food, cosmetic and drug registration choices. Each option states its prerequisites, the identifier help included, the filing covered, when U.S. Agent coverage ends, what is excluded, the completion evidence you receive, the next recurring cost and the FDA government fee position. The food options, for example, distinguish a facility that already has a matching DUNS number from one that needs DUNS acquisition, and an exporter that already has an acceptable U.S. Agent can request a written filing-only quote instead of buying an Agent transfer.
FDABridge describes its process in three steps: choose the work, agree the scope, then keep the evidence. Prerequisites, included work and any separate fees are confirmed before the service begins, and at the end you receive the applicable submission or review record with an explanation of next steps.
4. U.S. Agent Year 1 in selected offers, on stated terms
A foreign food facility that must register has to name a U.S. Agent in its registration, and FDA's regulation makes that agent the communications link between FDA and the facility for routine and emergency matters. FDABridge includes U.S. Agent Year 1 in selected registration offers, including the Food Starter and Cosmetics Starter bundles and the drug establishment registration service. Not every offer includes it: the filing-only cosmetic facility registration service requires an agent the facility has already appointed.
The terms are stated rather than implied. Year 1 lasts 12 months from the effective, accepted designation in the FDA record, it does not renew automatically, and continued coverage needs a separate written scope, quote and payment. Agent coverage by itself does not include registration or renewal filings, product listings, label review, Prior Notice, FSVP or importer services, customs brokerage, legal representation or inspection responses, as the U.S. Agent page states. The role itself is explained in what an FDA U.S. agent does for each product type. If you already have an agent and are considering a change, see how switching your FDA U.S. agent to FDABridge works.
5. A website published in 27 languages
fdabridge.com is published in 27 languages, from Spanish, Portuguese and Arabic to Bengali, Uzbek, Kiswahili and Amharic. The language menu switches the service descriptions, the pricing comparison and the FAQ to translated versions. For exporters whose language is on the list, the people who approve an order, such as the owner, the quality manager or the finance team, can read the prerequisites, inclusions and exclusions in that language before any work starts.
6. Plain statements about what registration is and is not
FDABridge's pages say what a filing does not do. Registration is not FDA approval of a facility or product and does not guarantee import clearance, and FDA does not issue food registration certificates, as the food facility registration page states. A cosmetic registration number or submission is not FDA approval, certification or a promise of market admission. FDABridge also describes itself as an independent service provider that is not affiliated with FDA and does not act on FDA's behalf.
These statements match FDA's own position. FDA charges no fee to register a food facility, does not require facilities to use a third-party registrar and is not affiliated with private registration businesses. It does not issue certificates of registration, and it does not recognize certificates issued by private businesses. FDABridge's food page likewise says that FDA charges no registration or renewal fee and that facilities may file directly with FDA. If you have been offered an ‘FDA certificate’, read our guide to FDA registration certificates and proof of registration first.
How FDABridge helps
Start with the page for your product: food facility registration, cosmetic facility registration or drug establishment registration. Compare bundles and individual services on the pricing page, and use the contact page to request a written scope if your facility role or records are unclear. For questions to put to any provider, FDABridge included, see red flags and questions to ask an FDA registration service. To compare specific offers term by term, see what to check before you pay for FDA registration.
Sources: FDA, Questions Regarding Whether Food Facilities are Required to Pay Registration Fees and Private Businesses Claiming or Suggesting an Affiliation with FDA (https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/questions-regarding-whether-food-facilities-are-required-pay-registration-fees-and-private); 21 CFR 1.227, definition of U.S. agent (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/section-1.227); 21 CFR 1.232, information required for foreign facilities (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/section-1.232).