FDA Entry Point
FDA Entry Point is a private compliance firm, not a government agency. We’re an FDA-registered U.S. Agent for foreign manufacturers and importers, handling registration and communication with The FDA.
FDA Entry Point is the legally required U.S. point of contact between your company and the FDA. We handle registration, compliance communication, and renewals, so you keep selling in the U.S. market without interruption. For foreign companies navigating the complex U.S. regulatory landscape, a US agent relationship isn’t just a legal formality: it’s a critical partnership. The importance of personal attention in this dynamic cannot be overstated. A great US agent goes beyond simply being a mailing address; they act as a reliable, human liaison who understands the client’s unique business needs and regulatory challenges. This personalized approach builds trust, ensures clear communication, and provides peace of mind, especially when time-sensitive matters arise. Tell us your products and which FDA center applies (Food, Drugs, Cosmetics, or Medical Devices). We file your U.S. Agent designation. The FDA contacts us, not you. We relay anything urgent immediately and handle routine communication on your behalf. We track your renewal deadlines and registration updates so nothing lapses and your market access stays uninterrupted. Start your registration today and keep your products moving without interruption. Helping domestic and foreign businesses achieve and maintain FDA compliance with confidence. Based in the United States.
Facts
More about our services
FDA Entry Point is a U.S. Agent and full-service FDA compliance firm based in Gainesville, Florida, serving foreign manufacturers and importers across all four FDA-regulated verticals: food and beverage, drugs and pharmaceuticals, cosmetics, and medical devices. Co-founded by a PhD with direct FDA experience. U.S. Agent service is $295 per year, with itemized pricing for the filings around it and no per-communication charges. Beyond the agent designation we file and maintain facility and establishment registrations, product listings (NDC, cosmetic product listing, device listing), SPL submissions through FDA's Electronic Submissions Gateway, GUDID/UDI entries, Prior Notice for food imports, MoCRA Responsible Person designation, INCI and food label review, and FSVP agent work performed on the importer's behalf. We track renewal deadlines per vertical so registrations do not lapse, handle agent transfers from an existing provider, and offer same-day response for detained shipments, import alerts and lapsed-agent emergencies.
HQ:
Jacksonville, United States
Languages:
English
Timezones:
UTC-5
Claim status:
Claimed
Services & Capabilities
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Jurisdictions:
Global
Countries:
United States
Industries:
Food & Beverages, Drugs & Pharma, Cosmetics, Medical Devices, Pharmaceuticals
Portfolio:
1-5, 6-25, 26-100
Flags:
multi_country_coverage
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
USD 295
Included services:
Food Facility Registration, Prior Notice for Food Imports, Food Label Review, Drug Establishment Registration, Drug Product Listing (NDC), Cosmetic Facility Registration, Responsible Person Designation
Product Type:
devices, food, cosmetics, drugs
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Time Zone Coverage:
US Eastern
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
Yes
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