Why 2,800+ Companies Choose Assurentry
The modern platform for FDA compliance. Transparent pricing, same-day processing, free compliance tools, and expert regulatory support — all for $399/year.
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2,800+
Facilities registered
160+
Countries served
< 24hr
Processing time
99%+
On-time renewals
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. At $399/year with no hidden fees, Assurentry offers same-day processing, a self-service platform with 24 free compliance tools, and dedicated regulatory experts. Trusted by 2,800+ companies in 160+ countries 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 $399/year for all facility types. No hidden fees, no surprise charges, no per-communication costs. Published pricing that every company can see upfront.
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.
Expert Support Team
Dedicated compliance managers with decades of FDA regulatory experience. 2-hour SLA for emergency FDA contacts. Real experts, 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 | $399/year, flat rate | 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 | 2-hour SLA for emergencies | Email only, no SLA |
| 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 |
Trusted by Global Enterprises
Enterprise-grade security and compliance for companies of every size.
2,800+
Companies trust us
Across all FDA product categories
160+
Countries served
Global regulatory expertise
< 24hr
Average processing
Same-day filing for most cases
99%+
On-time renewals
Never miss a deadline
Client Testimonial
“As a small pharmaceutical company entering the US market, we needed an experienced US Agent. Assurentry delivered exactly what we needed.”
Thomas R.
CEO, International Pharma Startup
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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Trusted by 2,800+ companies in 160+ countries