FAQs
International & Foreign Manufacturer

Q20: Does Landrich Group serve clients outside the United States?

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Yes. Landrich Group works with IVD, medical device, and biopharma companies globally. Our clinical and regulatory experience spans six continents, and a significant portion of our client work involves international manufacturers navigating U.S. FDA requirements — whether seeking FDA pre-sub feedback, 510(k) clearance, Premarket Approval (PMA), or De Novo classification for the first time.

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We serve as U.S. Agent for foreign manufacturers who need a U.S.-based FDA contact, and we support companies in managing parallel U.S. and international regulatory strategies. This includes EU IVDR submissions, MDSAP alignment, and multi-market clinical study design.

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Our office is based in Alameda, California, and we operate across time zones to support clients in Asia, Europe, Latin America, and other international markets. For manufacturers entering the U.S. market for the first time, we typically begin with a regulatory strategy assessment to identify the right pathway, timeline, and evidence requirements for your specific device and intended use.

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The Landrich Group serves as the U.S. Agent and provides CRO, Quality, and Regulatory entire product lifecycle consulting services to small and global multinational medical device and IVD companies to ensure integrated regulatory strategies to comply with the U.S. FDA and other National Competent Authorities (NCAs). The Landrich Group has also managed medical device, IVD, and Companion Dx clinical trials in the U.S., EU, and China for foreign clients and other collaborators.

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