Avoid FDA drug detention.
Secure your US agent in 12 minutes.
21 CFR 207.69 demands a physical U.S. presence for all foreign drug manufacturers. We guarantee instant CDER acceptance and full liability protection for a flat $399/year. Stop paying $1,300+ to legacy consultants.
No hidden fees • Cancel anytime • 100% FDA acceptance
Facility
CDER Node
Import Alert 66-40 is triggered instantly.
If your drug establishment registration lapses, or if your U.S. Agent fails to respond to an FDA inquiry, your facility is automatically placed on FDA Import Alert 66-40. Every shipment you send to the U.S. will be halted at the port. Demurrage fees start immediately, ruining distribution contracts.
Instant CBP unblocking • Immediate digital certificate
Entry Refused
HOLD: IMPORT ALERT 66-40
The hidden fee trap.
Legacy regulatory firms lure you in with a $449 base fee, then charge $349 for Labeler Codes, $199 for NDCs, and $399 for DUNS assistance. You end up paying $1,396+. We believe in one flat rate: $399/year.
"Each foreign establishment must designate one person who resides or maintains a place of business in the United States to be its U.S. agent... The use of a post office box does not meet this requirement."
P.O. Box / Virtual
Assurentry HQ
The physical presence mandate.
21 CFR 207.69 dictates you cannot use a virtual office, a P.O. Box, or an answering machine. The law is absolute. We provide a guaranteed legal foothold in the United States.
- Geographic Reality: Must reside in the US.
- 24/7 Availability: FDA emergency contact.
- Legal Proxy: Representations are legally binding.
100% compliant with 21 CFR 207.69
The FDA re-inspection liability trap.
Under GDUFA and FSMA, the U.S. Agent is financially liable for FDA re-inspection costs (often exceeding $10,000). Competitors refuse to act as agents or charge massive retainers. Assurentry absorbs this risk.
FDA Re-inspection Bill
The FDA bills the U.S. Agent directly for all facility re-inspection costs. If the agent does not pay, your facility registration is suspended.
Assurentry Shield
Because of this massive financial liability, legacy competitors force you to sign predatory contracts or deposit $10,000+ into an escrow account just to act as your agent.
Our corporate liability insurance absorbs the risk, meaning you keep your capital while maintaining perfect FDA compliance.
Included free with your $399 flat fee
Translating CDER legalese.
When the FDA sends a Form 483 or Warning Letter, it is written in dense regulatory code. Misinterpreting it can lead to facility suspension. We translate the risk into an actionable CAPA plan.
During an inspection of your firm located at the above address on [DATE], an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures drug products.
We found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR parts 210 and 211).
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Flawless SPL & ESG integration.
Unlike food facility registration, drug listings must be submitted to the FDA via the Electronic Submissions Gateway (ESG) using raw SPL XML files. Our U.S. Agent details perfectly match your SPL payloads.
FDA ESG & SPL Integration.
Unlike food registrations which use web portals, drug establishments and product listings must be submitted to the FDA via the Electronic Submissions Gateway (ESG) using raw SPL XML files.
Seamless SPL Connection
We ensure your U.S. Agent details perfectly match your SPL XML payloads, preventing ESG rejection errors.
Mastering the FEI disconnect.
The exact spelling and address format in the FDA database must cryptographically match the Dun & Bradstreet database to generate your FDA Establishment Identifier (FEI). If it doesn't, your registration fails.
Dun & Bradstreet
FDA CDER DB
The Notice of Inspection (NOI) interceptor.
When the FDA decides to inspect your foreign drug facility, they call your U.S. Agent first to schedule it. A missed call flags you as non-cooperative. We intercept, negotiate dates, and prep your QA team.
U.S. Agent
FDA"We are scheduling a CGMP inspection of your client's facility in 5 days. Confirm receipt."
Without an agent answering, the FDA flags the facility for non-cooperation immediately, putting all U.S. distribution at risk.
Triage
The annual renewal trap.
Unlike food facilities (biennial), drug establishment registrations must be affirmatively renewed every single year between October 1 and December 31. Assurentry automatically files your renewal paperwork via SPL for free. You will never wake up on January 1st to a cancelled registration.
Included free with your subscription
Annual Renewal
Unlike food facilities, drugs require renewal every single year.
Auto-Renewal
Our system automatically initiates the annual renewal via the FDA ESG, verifying DUNS and FEI matches free of charge.
FDA emergencies wait for no one.
The FDA operates on EST. If an adverse event or recall notice is sent at 4:00 PM EST, it might be 4:00 AM in your country. We provide 24/7/365 coverage for over 160+ countries.
CDER emergencies wait for no one.
The FDA operates on U.S. Eastern Standard Time (EST). If an emergency communication is sent at 4:00 PM EST regarding an adverse event or recall, it might be 4:00 AM in your country. The FDA expects the U.S. Agent to answer immediately.
24/7/365 Coverage
We support over 160+ countries. When the FDA calls, we answer on the first ring.
The secure audit vault.
Every CDER interaction, establishment registration, and NDC labeler code is cryptographically stored and instantly accessible for your buyers or inspectors.
Regulatory Document Vault
Every CDER interaction, establishment registration, and NDC labeler code is cryptographically stored and instantly accessible.
U.S. Agent Designation Cert
Establishment Registration
NDC Labeler Code Record
Radical transparency.
We answer the hard questions our competitors won't.
One flat fee. Complete peace of mind.
Stop paying hourly retainers for mandatory compliance.
U.S. agent designation
The complete compliance representation package for pharma.
Secure SSL checkout. No setup fees. Cancel anytime.
What's included:
- Official 21 CFR 207.69 Designation
- Liability Shield (Re-inspection fees)
- Free Annual Renewal Filing
- ESG & SPL Validation Support
- Free DUNS Validation Support
- Unlimited FDA Comm Handling
- Digital Compliance Certificate
Certificate of Designation
U.S. AGENT FOR PHARMACEUTICALS
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.