FDA Compliance Experts You Can Trust
Assurentry is the modern platform for FDA regulatory compliance. We provide transparent, reliable U.S. Agent services so companies in 160+ countries can focus on their business — not bureaucracy.
Trusted by 2,800+ companies in 160+ countries
2,800+
Companies served
160+
Countries
< 24hr
Processing time
99%+
On-time renewals
What Is Assurentry?
Assurentry is an FDA compliance platform that provides U.S. Agent services, facility registration support, and regulatory tools for foreign establishments. Founded to make FDA compliance accessible to companies of all sizes, Assurentry serves 2,800+ companies in 160+ countries with transparent $399/year pricing, same-day processing, and 12+ free compliance tools across food, drugs, devices, and cosmetics. Explore our services and U.S. Agent workflows to see what fits your team.
Making FDA Compliance Accessible to Everyone
We believe every company — regardless of size or location — deserves access to clear, affordable FDA compliance support. That's why we built Assurentry: a modern platform that replaces confusing paperwork and opaque pricing with self-service tools and transparent flat rates.
The Principles That Guide Us
Transparency
Published pricing. No hidden fees. No surprise invoices. Every company — from startups to multinationals — gets the same honest pricing and clear communication.
Expertise
Our team has decades of combined FDA regulatory experience across food, drugs, devices, and cosmetics. We know 21 CFR inside and out — from Part 1 to MoCRA.
Reliability
We respond to FDA contacts within hours, not days. 2-hour SLA for emergency FDA communications. 99%+ on-time renewal rate across all facility types.
Innovation
Modern self-service platform with real-time dashboards, automated reminders, 12+ free compliance tools, and API access. Technology-first approach to regulatory compliance.
Accessibility
We believe every company — regardless of size or location — deserves access to clear, affordable FDA compliance support. That's why we built Assurentry.
Global Reach
Supporting companies in 160+ countries across all FDA product categories. Multilingual support and experience with regulatory requirements worldwide.
What Sets Us Apart
Faster, more transparent, and more reliable than legacy FDA compliance providers. Every feature is designed to save you time and eliminate uncertainty.
Learn more about our approachTransparent Pricing
Flat-rate $399/year for all facility types. No hidden fees or surprise charges.
Same-Day Service
Acceptance letters within the same business day. Most cases processed within hours.
Self-Service Platform
Complete onboarding in 6-12 minutes. Real-time dashboards and automated reminders.
Expert Support
Dedicated compliance managers with decades of FDA experience. 2-hour emergency SLA.
12+ Free Tools
Requirement checkers, deadline calculators, label reviewers, and more — all included.
CFR-Compliant
Every step follows 21 CFR requirements. Registrations done right the first time.
Meet the Team
Experienced regulatory professionals dedicated to simplifying FDA compliance for companies worldwide.
Sarah Chen
Chief Executive Officer
15+ years in FDA regulatory affairs. Previously led compliance at a Fortune 500 pharmaceutical company.
James Okafor
VP of Regulatory Affairs
Former FDA reviewer with deep expertise in device and drug establishment registration.
Maria Gonzalez
Head of Client Success
Ensures every client receives responsive, knowledgeable support throughout their compliance journey.
David Park
Chief Technology Officer
Built Assurentry's platform from the ground up with a focus on security, speed, and usability.
“Their MoCRA compliance support was invaluable during the transition. They guided us through every step of cosmetic facility registration.”
Linda Chen
VP of Regulatory, Cosmetics Brand
About Assurentry
Common questions about who we are and what we do.
Explore Our Resources
Ready to Begin?
Join 2,800+ companies that trust Assurentry for FDA compliance. Start in minutes with our self-service platform.
Trusted by 2,800+ companies in 160+ countries