What does Assurentry do?

Assurentry is an FDA compliance platform that provides U.S. Agent services, facility registration support, and regulatory tools for foreign establishments. We help companies worldwide navigate FDA requirements for food, drugs, medical devices, and cosmetics, including MoCRA compliance.

How long has Assurentry been in business?

Assurentry launched in 2024 to modernize FDA compliance, with workflows covering FDA requirements across all product categories. We serve companies worldwide across food, drugs, devices, and cosmetics.

What makes Assurentry different from other providers?

Transparent published pricing (U.S. Agent from $199/year), same-day submission to FDA in most cases, a self-service online platform with 30+ free compliance tools, and an experienced regulatory team. We're built from the ground up as a modern, technology-first compliance platform — not a legacy consulting firm.

Is Assurentry a legitimate U.S. Agent provider?

Yes. Assurentry is a fully compliant U.S. Agent provider under 21 CFR. We are physically located in the United States, available during business hours to respond to FDA inquiries, and protect your data with AES-256 encryption, built on cloud infrastructure that maintains SOC 2 Type II certification. We act as the designated U.S. Agent for foreign establishments under 21 CFR.

How can I contact Assurentry?

You can reach our team through our contact page at assurentry.com/contact, or start your registration directly at assurentry.com/checkout. Our regulatory team responds to inquiries within one business day, with a 2-hour SLA for emergency FDA communications.

About Assurentry

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 foreign facilities worldwide can focus on their business — not bureaucracy.

Talk to an Expert

Built for FDA-regulated brands

$199/yr

U.S. Agent — transparent pricing

30+

Free tools

< 24hr

Submission turnaround

Same-day

Submission to FDA

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 FDA-regulated companies with transparent published pricing (U.S. Agent from $199/year), same-day submission to FDA in most cases, and 30+ free compliance tools across food, drugs, devices, and cosmetics. Explore our services and U.S. Agent workflows to see what fits your team.

$199

Transparent Pricing

States Covered

FDA

Requirements-Aligned

24/7

Support

Our mission

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.

Our values

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 platform covers FDA regulatory requirements across food, drugs, devices, and cosmetics — with workflows built on 21 CFR, from Part 1 to MoCRA.

Reliability

We respond to FDA contacts within hours, not days, with priority response targets for emergency FDA communications. We track renewal windows proactively across all facility types.

Innovation

Modern self-service platform with real-time dashboards, automated reminders, 30+ 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 worldwide across all FDA product categories. Multilingual support and experience with regulatory requirements worldwide.

Why Assurentry

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 approach

Transparent Pricing

Published flat rates — U.S. Agent from $199/year. No hidden fees or surprise charges.

Fast Submission

We prepare and submit your filing to FDA the same business day in most cases. FDA processing then follows its own timeline.

Self-Service Platform

Complete onboarding in minutes. Real-time dashboards and automated reminders.

Expert Support

Compliance specialists available during business hours, with priority response targets for emergency FDA communications.

30+ Free Tools

Requirement checkers, deadline calculators, label reviewers, and more — all included.

CFR-Aligned

Every workflow is built around the applicable 21 CFR requirements.

Leadership

How Our Team Is Organized

Four functions work together to simplify FDA compliance for companies worldwide — from regulatory strategy to engineering.

Regulatory Affairs

FDA filing & strategy

Maps each product to the right FDA pathway across food, drugs, devices, and cosmetics, and prepares submissions for filing.

Compliance Operations

Registration & renewals

Runs the registration, listing, and renewal workflows and tracks deadlines so filings stay current.

Client Success

Onboarding & support

Guides every customer through onboarding and provides responsive support throughout their compliance journey.

Engineering

Platform & security

Builds and maintains the Assurentry platform with a focus on security, speed, and usability.

From food facility registration and U.S. Agent designation to MoCRA cosmetic listing and medical device filings, Assurentry guides you through each FDA requirement step by step — preparing and submitting your filings while keeping renewal windows on track.

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FAQ