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FDABridge

FDA registration and U.S. Agent work, matched to your product

FDABridge helps non-U.S. companies choose the applicable FDA filing or U.S. Agent service, agree the scope, and keep the resulting record. EU market services are available separately.

Confirm the records, authorized access and service scope before proceeding. Do not send FIS/FURLS passwords or PINs.

From scope to a usable record

The work follows the agreed service. FDA decisions and authority timing remain with the relevant authority.

  1. 01

    Choose the work

    Tell us your product, role and current records so the right service can be identified.

  2. 02

    Agree the scope

    Confirm prerequisites, included work and any separate fees before the service begins.

  3. 03

    Keep the evidence

    Receive the applicable submission or review record and an explanation of next steps.

Questions before you order? Speak with FDABridge about the product, facility role and records you already have; the agreed work is documented before it begins.

Contact us

Bundles

A defined place to start

Choose by the records you have and the work you need. The full comparison covers other buyer states.

View Pricing

Need DUNS and first food registration

Food Starter

$449/ one scoped service

DUNS acquisition assistance · Food facility registration filing · U.S. Agent Year 1

No FDA food facility filing fee. Agent Year 1 is included; later coverage is separately quoted.

Start food application

Need FEI and MoCRA facility filing

Cosmetics Starter

$449/ one scoped service

FEI acquisition assistance · MoCRA facility-registration filing · U.S. Agent Year 1

No MoCRA facility or product-listing FDA filing fee. Agent Year 1 is included; later coverage is separately quoted.

Start cosmetics application

Drug establishment registration

Drug establishment

$499/ one scoped service

Drug establishment registration · U.S. Agent Year 1

Applicable FDA drug programme fees are separate; confirm by activity and fiscal year. FEI and product listing are separate.

Request drug scope

Included U.S. Agent Year 1 runs for 12 months from accepted FDA-record designation. Coverage after that needs a separate written scope and payment; it does not renew automatically. The offer pages show prerequisites and exclusions.

We work with foreign manufacturers that need a clear, practical path into the US market without getting lost in FDA paperwork.