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US Agent for Foreign Companies
Per FDA's requirements, all foreign establishments who manufacturer any of drugs, biological products and medical devices must have a designated agent in the USA. Allura Medical Solution, Inc. works the below activities based on the responsibilities outlined by the FDA.
Per FDA's requirements, all foreign establishments who manufacturer any of drugs, biological products and medical devices must have a designated agent in the USA. Allura Medical Solution, Inc. works the below activities based on the responsibilities outlined by the FDA.
- U.S. Agent Program for Pharmaceutical / Medical Device Manufacturers
- Keep a physical office in the USA
- Provide updates of the establishment registration and product listing
- Be responsible to provide communications between the FDA and the Company, ie. upcoming inspections of the foreign site
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