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Request a Compliance Assessment

Project-based service

U.S. FDA Compliance

Registration, listing, labeling, technical documentation, and import-readiness support for food, cosmetics, and medical devices entering the U.S.

Service overview

Registration, listing, labeling, technical documentation, and import-readiness support for food, cosmetics, and medical devices entering the U.S.

Products that may apply

  • Food
  • Pet food
  • Cosmetics
  • Medical devices
  • Products potentially subject to FDA import oversight

Who may hold regulatory responsibility

Importers, brands, manufacturers, U.S. agents, and responsible parties may have different obligations depending on product facts, transaction structure, and import model.

Materials we need from you

  • Product name, use, and target market
  • Formula, ingredients, specifications, or technical data
  • Labels, IFU, website claims, or sales claims
  • Manufacturer, importer, and U.S. contact details
  • Existing test reports, registrations, or agency notices

What we provide

  • Initial regulatory pathway assessment
  • Document checklist and gap mapping
  • Registration, listing, or filing preparation support
  • Labeling and claims review
  • Import-readiness file coordination

What is not included

  • Guarantees of agency clearance or approval
  • Legal opinions or litigation support
  • Laboratory and official fees
  • Risks caused by undisclosed product information

Process

  1. 01

    Collect product and transaction facts

  2. 02

    Assess FDA pathway and responsible parties

  3. 03

    Confirm scope, quote, and document list

  4. 04

    Prepare or review files

  5. 05

    Support filing or deliver the file package

  6. 06

    Coordinate import and ongoing compliance next steps

Deliverables

  • Pathway note
  • Document gap list
  • Label or technical file comments
  • Registration/listing support record
  • Next-action plan

Timing notes

Timing depends on product type, document completeness, system availability, and whether supplemental review is needed.

Official fee notes

FDA-related, third-party, testing, U.S. agent, or official fees will be listed separately when applicable.

FAQ

Is FDA registration the same as FDA certification?

No. Registration, listing, or filing support should not be described as FDA certification or official endorsement.

Can 510(k) or De Novo be ordered directly?

Not as a simple checkout item. These projects require classification and pathway assessment before scope, files, and timeline can be confirmed.

Disclaimer

FDA obligations may vary by formula, intended use, claims, responsible party, and import model. Final obligations require review of complete product facts.