FDA Entry Point
FDA Entry Point is a private compliance firm that serves as the FDA-registered U.S. Agent for foreign manufacturers and importers selling into the United States. We are not a government agency, a government portal, or the FDA itself. We’re the legally required U.S. point of contact between your company and the FDA, handling registration, ongoing communication, and compliance across four regulated categories: food and beverage, cosmetics, drugs and pharmaceuticals, and medical devices.
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.
HQ:
United States
Languages:
English
Timezones:
UTC-5
Claim status:
Claimed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
Global
Countries:
United States
Industries:
Food & Beverages, Drugs & Pharma, Cosmetics
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 Pacific
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
Yes
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare FDA Entry Point and other vetted providers — instant pricing, no RFQ needed.
