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ST&T Home > Client Services > Regulatory / Law Services > US Local Agent Services
Corporate US Local Agent Services

The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.

Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.

--> click here for FDA US Local Agent Regulation <--

Find listed below the US Local Agent Services we offer:

  • Registration of Foreign Establishment with US FDA to Obtain product Labeler Code
  • Prepare & File FDA 2657 forms to list products with US FDA & Customs
  • FDA Registration (Medical Device Establishment)
  • Medical Device
  • New Device filings 510 K "Pre Market Notification applications/registration"
  • Prepare and file annual registration of establishment
  • Respond to regulatory or legal related issues
  • Respond to consumer product inquiries or complaints
  • Investigate FDA/FTC or consumer complaints
  • Other certificates provided upon request
    • Certificate of Free Sale
    • International Product Ingredient Health review Certification to assist in your export of products from the US.
  • Reportable Food Registry
 




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