FDA Compliance,
Automated.
Stop paying consultants for manual PDF filings. Assurentry is the only API-native platform for instant US Agent Designation, MoCRA Registration, and Label Verification.
Don't just get a mailbox.
Get a Shield.
Cheap US Agents are just mail-forwarding services. When the FDA inspects, you need an expert in the room. Assurentry provides 24/7 regulatory representation by certified professionals who actually protect your brand.
1-Hour Response
We respond to FDA calls immediately, preventing minor issues from becoming detentions.
Physical Office
A legitimate Delaware business address for official service of process. No PO boxes.
Instant Acceptance Letter Included
Sarah Miller
RAC CertifiedSenior Regulatory Specialist
Cosmetics Regulation,
Demystified.
The MoCRA grace period is over. All cosmetic facilities must be registered, and every product must be listed with the FDA. Assurentry generates your **SPL files** automatically—no XML coding required.
Facility Registration (Form 5066)
Link manufacturing sites to your brand in one click.
Product Listing (Form 5067)
Bulk upload formulas & labels. Direct submission to FDA Direct.
Adverse Event Reporting
Mandatory MedWatch form generation for serious events.
POST /api/v1/mocra/facility-registration
{
"facility_name": "Glow Labs LLC",
"duns_number": "04-123-4567",
"product_categories": ["Skincare", "Makeup"],
"inci_validation": true
}
> "message": "FEI Assigned Successfully"
Unified
Regulatory Command
Everything you need to enter the US market. No silos. No spreadsheets. Just one active dashboard for Food, Drugs, Devices, and Cosmetics.
From Audit Riskto Audit Ready
See how Assurentry transforms your raw supply chain data into FDA-verified compliance in seconds.
The Middleware for
Global Supply Chains
Compliance data shouldn't live in spreadsheets. Assurentry acts as the secure middleware layer between your ERP/PLM systems and regulatory authorities, ensuring single-source-of-truth accuracy.
Master Data Sync
Eliminate manual entry. Bi-directional sync with SAP S/4HANA, Oracle Cloud, and NetSuite ensures your FDA filings match your ERP.
Immutable Audit Trails
Every ingredient change, label update, and registration renewal is versioned and cryptographically signed. FDA-audit ready instantly.
Bank-Grade Security
SOC 2 Type II Certified. SAML/SSO integration with Okta and Azure AD. Granular RBAC for global teams.
Event-Driven Webhooks
Trigger workflows in your WMS when a facility is registered or an import alert is issued. Real-time 'status.changed' events.
Pro V2
Class I, II, or III?
We Handle the Listing.
Medical device registration is more than just a form. It requires precise **Product Code** selection, **510(k)** linkage, and **UDI** coordination. Assurentry manages the entire FURLS lifecycle for you.
Product Code Verification
We verify your 3-letter product code against the FDA database to prevent misclassification (e.g., distinguishing Class I exempt vs 510(k)).
Listing & GUDID Sync
We ensure your FURLS device listing matches your GUDID records, preventing import holds due to data mismatches.
Don't just file.
Prove it.
MoCRA §608 requires you to maintain records supporting the safety of every product. Our Safety Substantiation Vault™ organizes your toxicology reports, testing data, and ingredient safety files in one FDA-ready digital locker.
Centralized Evidence
Stop scrambling for PDFs during an inspection. Link safety data directly to your product listings.
Ingredient Risk Scanner
Automatically flag "prohibited" or "restricted" ingredients (like Chloroform or Mercury) before you submit.
Catch Labeling Errors
Before the FDA Does
Misbranding causes 60% of FDA detentions. Our Label Shield™ AI scans your packaging against 5,000+ regulations in seconds—checking ingredients, claims, and formatting instantly.
Don't Get Stuck on the
Red List.
FDA Import Alerts (the "Red List") cause automatic detention of shipments at the border. Assurentry scans your entire supply chain daily against the FDA's blacklist database.
Don't overpay for
Legacy Paperwork
Traditional registrars charge per-certificate fees and hold your data hostage. Assurentry is transparent, instant, and gives you full control.
*Comparison based on publicly available pricing and service data as of Q1 2026.
Predictable compliance outcomes
across every region
Whether you're importing cosmetics from Seoul or medical devices from Berlin, Assurentry's platform standardizes the regulatory workflow. We map local requirements to FDA standards automatically.
Trusted by the
Best in the Industry
"We used to pay a consultant $5,000/year just to hold our US Agent registration. Assurentry does it automatically via API for a fraction of the cost. The dashboard catches FDA FURLS issues before they even happen."
"The MoCRA filing engine is incredible. We dropped our legacy registrar, uploaded our entire SKU list, and the platform generated all the SPL files and INCI validations instantly. FDA Cosmetics Direct accepted them same-day."
"Our shipment was detained at the Port of LA due to a missing Prior Notice. Assurentry's automated system generated the filing and cleared the detention in 48 hours. They saved $200k in perishable inventory."
"Finally, a compliance tool that operates like modern software. We use the Label Shield AI to scan all our packaging before production. It caught a 21 CFR 101 formatting error that would have caused a massive recall."
Everything You
Need to Know
Can't find the answer you're looking for? Chat with our regulatory team.
Ready to modernize your
Compliance Stack?
Join 2,800+ innovative companies who have switched from legacy consultants to Assurentry's automated infrastructure.
Rated 4.9/5 by Regulatory Professionals