Why FDA-Regulated Brands Choose Assurentry
The modern platform for FDA compliance. Transparent pricing, same-day processing, free compliance tools, and a dedicated regulatory support team — with U.S. Agent representation for $199/year.
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$199/yr
U.S. Agent, flat rate
24
Free tools
< 24hr
Processing time
Same-day
Acceptance letters
Why Choose Assurentry for FDA Compliance?
Assurentry is a modern FDA compliance platform that provides U.S. Agent services, facility registration, and regulatory support for foreign establishments. With U.S. Agent representation at $199/year and no hidden fees, Assurentry offers same-day processing, a self-service platform with 24 free compliance tools, and a dedicated regulatory support team. Built for FDA-regulated brands across food, drugs, devices, and cosmetics.
What Makes Us Different
Built from the ground up to be faster, more transparent, and more reliable than legacy FDA compliance providers.
Transparent Pricing
Flat $199/year for U.S. Agent representation. No hidden fees, no surprise charges, no per-communication costs. Every service price is published upfront so you can see exactly what you pay.
Same-Day Processing
Receive your FDA acceptance letter within the same business day. Most designations are filed within hours — not days or weeks.
Self-Service Platform
Complete your entire onboarding online in 6-12 minutes. Real-time dashboards, automated reminders, and API access for enterprise integration.
Dedicated Support Team
A dedicated regulatory support team handles your account and prioritizes urgent FDA contacts. Real people who know FDA compliance workflows — not call-center scripts.
24 Free Compliance Tools
Requirement checkers, deadline calculators, label reviewers, import alert monitors, and more — all included free with every account.
CFR-Compliant Processes
Every procedure is built around 21 CFR compliance requirements. Your registrations are done right the first time — across food, drugs, devices, and cosmetics.
Begin in Four Steps
From intake to ongoing compliance — we handle everything so you can focus on your business.
Submit your details
Complete our guided intake form with your facility information. Takes about 10 minutes — no phone calls or faxes required.
We file with FDA
Our team files your U.S. Agent designation and handles all documentation and communication with the agency.
Receive your documents
Get your official FDA acceptance letter and authorization documents within one business day.
Ongoing compliance support
We monitor deadlines, handle FDA communications, and keep you ahead of regulatory requirements year-round.
Assurentry vs Traditional Providers
See how we compare on the things that matter most.
| Feature | Assurentry | Traditional Providers |
|---|---|---|
| Annual Pricing | $199/year, flat rate (U.S. Agent) | Hidden fees, quotes only |
| Onboarding Time | 6-12 minutes online | Days or weeks of paperwork |
| Acceptance Letter | Same business day | 3-5 business days |
| FDA Response Time | Target ~2-hour response for urgent items | Email only, no priority handling |
| Technology Platform | Real-time dashboard + API | Manual email updates |
| Compliance Tools | 24 free tools included | None included |
| Renewal Reminders | Automated, multi-channel | Manual, if at all |
| Industries Covered | Food, drugs, devices, cosmetics | Usually limited to 1-2 |
Built for Compliance Teams
Enterprise-grade security and compliance for companies of every size.
$199/yr
U.S. Agent pricing
Fixed, upfront annual rate — published online
24
Free compliance tools
Included with every account
< 24hr
Average processing
Same-day filing for most cases
Same-day
Acceptance letters
Once onboarding is complete
Frequently Asked Questions
Answers to common questions about Assurentry and our FDA compliance services.
Related Resources
Ready to Experience the Difference?
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Built for FDA-regulated brands