US 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.


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