FDA Compliance
U.S. Agent · Registration · Product Listing
The U.S. Food and Drug Administration (FDA) regulates a wide range of products including medical devices, drugs, foods, and cosmetics.
Any company involved in manufacturing, packaging, labeling, or importing these products into the U.S. must comply with FDA regulations—often starting with Establishment Registration, Product Listing, and appointing a U.S. Agent.
Who Needs FDA Compliance?
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Manufacturers and OEMs exporting to the U.S.
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Private label brand owners
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Importers and distributors
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Food and cosmetic producers
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Laboratories and contract packagers
If your company plans to sell medical devices, drugs, foods, or cosmetics in the United States, FDA compliance is a critical step before entry.
Why Choose CertiGlobe Visas
✅ Expert Knowledge — Deep understanding of FDA and embassy compliance processes.
✅ Authorized U.S. Presence — Based in Washington, D.C., serving as your reliable U.S. Agent.
✅ Global Communication — Clear and responsive support for international clients.
✅ Transparent Pricing — No hidden fees; fixed, clearly defined packages.
✅ Continuous Support — Annual reminders and status tracking to keep your registration active.
Our Services
FDA US Agent
Stay compliant with FDA requirements by designating CertiGlobe Visas as your official U.S. Agent.
We serve as your point of contact with the FDA—handling communications, notices, and annual verifications.
Medical Device
From classification and 510(k) submission guidance to device listing and annual renewal, CertiGlobe provides full support for medical device manufacturers entering the U.S. market.
FDA Registration
We help international manufacturers complete FDA Establishment Registration and Product Listing efficiently.
Our team ensures your information is properly filed and kept active in the FDA database.
Food/Dietary Supplement
Ensure your food or dietary supplement facility meets FDA standards.
We assist with FDA food facility registration, labeling guidance, and biennial renewals for safe and smooth import.