Supplier qualification

Build the route from verified facts.

Use this bilingual intake when a manufacturer or supplier is preparing a U.S. company, Amazon launch, FDA pathway, import route, or related operating setup.

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This is a qualification intake—not legal or regulatory advice, an approval promise, or acceptance of an FDA or importer role.

Before you begin

Start with the evidence you already have.

This intake establishes the current state, gaps, and next decision. Do not guess simply to complete it; use “not sure” where evidence still needs verification.

Company & product

Prepare company names, contacts, brand, exact product category, intended use, comparable products, and early sales expectations.

Compliance evidence

Where available, provide GMP and 510(k) records, FDA registration/listing evidence, labels, testing reports, and other certificates.

Structure & launch

Explain the current U.S. company, banking, Amazon, FDA U.S.-agent, inventory, FBA timing, and commercial preferences.