Navigating FDA Compliance? Your Trusted US Agent is Your Gateway to the US Market.
U.S. Agent Services Drugs & Pharma
Foreign drug and pharmaceutical establishments must designate a U.S. Agent before registering with the FDA. We serve as your official FDA representative managing all communications, coordinating inspections, and ensuring your drug establishment remains fully compliant year-round.
⏱ We respond to all inquiries within 24 business hours
Your U.S. Agent relationship can stay connected to drug establishment registration, NDC product listing, SPL preparation and submission, drug label review, and annual renewal tracking through one accountable team.
U.S. Agent Services Drugs & Pharma
Official Communication Hub
As your designated U.S. Agent, we act as the mandatory, primary FDA contact. All official correspondence, regulatory notices, and inquiries are received and forwarded to your team.
- Primary FDA point of contact
- DRLS system communications managed
- No missed notices due to time zones or language
- Regulatory inquiry handling
Inspection Coordination
We facilitate and coordinate FDA facility inspections for your drug establishment managing logistics and ensuring you are fully prepared for every visit.
- FDA inspection scheduling support
- Logistics coordination with your team
- Pre-inspection readiness guidance
- Post-inspection follow-up
Emergency Contact
For drug recalls, safety alerts, or public health emergencies, the FDA contacts us immediately ensuring your team is notified and can respond without delay.
- Recall & public health alert response
- Rapid notification to your team
- Protects company & public safety
Registration & Annual Support
We assist with drug establishment registration, DUNS number maintenance, drug product listing, and all annual renewal requirements.
- Drug establishment registration
- Annual renewal coordination
- DUNS number maintenance
- Drug product listing (NDC) support
Your Dedicated FDA Partner for Pharmaceuticals
From OTC drugs to prescription pharmaceuticals, our team understands the complexity of FDA drug regulations. Choosing the right U.S. Agent means partnering with experts who provide the personal attention your compliance demands.
Getting FDA compliant has never been easier
Step 1: Register & Designate
Complete our short form and designate FDA Entry Point as your U.S. Agent.
Step 2: We Confirm
We confirm and submit your FDA registration update within 1 business day.
Step 3: Active Coverage
We receive all FDA communications on your behalf immediately.
Step 4: Ongoing Renewal
We track and file your registration renewal on schedule, so there’s never a lapse in coverage.
becoming
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Drugs & Pharma Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before FDA registration; renew each year | $295/yr |
| Drug Establishment Registration | Domestic & foreign | Annual | October-December of each year | $449/yr |
| Drug Product Listing (NDC) | All drug manufacturers | Annual + per change | At registration; updated when products change | $299/product |
| Structured Product Labeling (SPL) | All drug manufacturers | Per submission | At listing submission & with each label update | $249/submission |
| Drug Label Review | All manufacturers | Per product/change | Before market entry or label revision | $449/product |
| Animal & Veterinary Drugs | Vet drug manufacturers | Annual | October-December of each year | $449/yr |
How to Change Your U.S. Agent
Already working with an agent? Here is how to switch to a new one without a gap in coverage.
Step 1: Select Your New U.S. Agent
Confirm the new agent agrees to the designation and provides a signed acceptance letter listing their U.S. address, phone number, and email address.
Step 2: Update Your Registration on DRLS
Log in to DRLS (the Drug Registration and Listing System) and update the U.S. Agent fields on your facility registration with your new agent’s contact information.
Step 3: Submit the Update
The change takes effect immediately upon successful submission. The FDA does not charge a fee for this update.
Step 4: Confirm With Your New Agent
Verify that your new U.S. Agent has received the registration confirmation and is ready to act on your behalf.
Step 5: Notify Your Former Agent
Let your outgoing agent know the change is complete so there is no confusion if the FDA reaches out to them during the transition.
Important Timing Note
Federal regulations require you to update your U.S. Agent information within 60 days of any change. Do not leave a gap in U.S. Agent coverage: if the FDA attempts to contact your facility through an outdated or non-functional agent, it can trigger enforcement action, including import refusal and registration cancellation.
US Agent Drugs & Pharma FAQs
A U.S. Agent is the FDA’s official point of contact for a foreign drug or pharmaceutical establishment. That means receiving and routing all FDA communications, helping coordinate facility inspections, and being reachable during U.S. business hours, year-round.
Yes. Under 21 CFR Part 207, a foreign drug establishment must designate a U.S. Agent before it can register with the FDA. The agent must have a physical U.S. address and be available during normal business hours; a P.O. box doesn’t qualify.
We help schedule inspections, coordinate logistics with your team, and provide pre-inspection readiness guidance so your facility isn’t caught off guard, plus manage post-inspection follow-up communications with the FDA.
The FDA contacts the U.S. Agent first. We’re available to receive that notification and relay it to your team immediately, so there’s no delay in responding to a recall or public health alert.