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
