USA Market
US Agent Services
Stay FDA compliant by designating a qualified U.S. Agent. We serve as your official regulatory liaison with the FDA, ensuring uninterrupted market access and proactive communication support.
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What Is US Agent Services?
US Agent is a mandatory FDA requirement for all foreign establishments involved in manufacturing, processing, or packaging drugs for the U.S. market.
The U.S. Agent acts as the FDA's official contact for:
Scheduling inspections
Addressing regulatory inquiries
Receiving emergency notifications
This applies to all foreign manufacturers registering with the FDA under Drug Establishment Registration and Listing requirements.
We provide comprehensive support by serving as your reliable U.S. Agent and ensuring timely compliance with all FDA obligations.
Why Is US Agent Services Important?
Maintain Market Access
A designated U.S. Agent is required for establishment registration and drug listing submissions. Without it, registration is incomplete and product entry to the U.S. is restricted.
Ensure Prompt FDA Communication
e receive and relay FDA notices in real-time—minimWizing the risk of missed inspections or regulatory actions.
Support During Inspections and Emergencies
We coordinate with your teams before, during, and after FDA interactions to ensure a compliant and confident response.
Regulatory Representation with Authority
Our experience in regulatory affairs ensures FDA queries are handled by professionals with industry knowledge.
Process Flow for US Agent Services
Designation and Notification Filing
We file U.S. Agent information accurately in FDA databases (CDER Direct or ESG portals) and ensure it’s linked to your establishment registration.
FDA Contact Management
We act as your ongoing FDA contact—handling communications, documentation requests, and inspection notices.
Inspection & Compliance Alerting
If an inspection is announced or triggered, we notify you promptly, help interpret the scope, and support compliance coordination.
Annual Update & Renewal Monitoring
We monitor registration renewal timelines and update your FDA records to maintain active status.
Emergency Communications
Should FDA require urgent action (e.g., recalls, alerts), we facilitate immediate response coordination.
How Can We Help in US Agent Services?
We are more than a name on a form—we are your strategic regulatory partner.
Experienced Regulatory Professionals: Over 15 years supporting international pharma clients with U.S. compliance.
End-to-End Support: From designation to daily communication management, inspection coordination, and record maintenance.
Real-Time Responsiveness: We ensure that time-sensitive FDA notices are never missed, and your compliance is never compromised.
FDA-Compliant Documentation: We maintain clean, audit-ready records to support your regulatory profile.
Who Needs a US Agent Services?
Any non-U.S. company involved in drug manufacturing, testing, or handling needs a U.S. Agent.​
Regulatory Requirements for US Agent Services
Documents
|
Document / Information​ |
Purpose​ |
|
Letter of Appointment / Authorization​ |
Required to designate the U.S. Agent formally. Often includes signatures from both the foreign firm and the agent.​ |
|
Agent’s Contact Details​ |
Full name, address (U.S.-based), phone, and email.​ |
|
Establishment Details of Foreign Entity​ |
Company name, DUNS number, address, product type (API, FDF, device, etc.).​ |
|
Device Firms: Registration via FURLS​ |
Establishment registration + Device listing (requires U.S. Agent for non-U.S. firms).​ |
|
Drug Firms: Submission via CDER Direct or ESG​ |
Facility registration and drug listing (includes agent info in SPL format).​ |
Timeline
Once submitted via FDA portals (e.g., FURLS, CDER Direct, ESG), designation is typically effective immediately unless flagged.​
The U.S. Agent may be contacted by FDA at any time—therefore, they must remain active year-round.​
Regulatory Body
U.S. Food and Drug Administration (FDA)The U.S. Agent designation remains valid for the duration of the FDA establishment registration cycle. Must be reconfirmed each year during the FDA’s registration renewal period. If you change your U.S. Agent, you must immediately update the designation in the FDA system.​
Fees
No specific FDA fee is charged solely for assigning a U.S. Agent.​
- Associated FDA Fees:​
- For Drug Establishment Registration and Drug Product Listing, companies may be subject to GDUFA facility fees (for finished dosage forms and API facilities).​
- For medical devices, FDA Device Facility User Fee (under MDUFA) applies at the time of establishment registration.​
Validity
The U.S. Agent designation remains valid for the duration of the FDA establishment registration cycle. Must be reconfirmed each year during the FDA’s registration renewal period. If you change your U.S. Agent, you must immediately update the designation in the FDA system.​
Frequently Asked Questions(FAQs)
Is a U.S. Agent the same as a distributor or importer?​
No. A U.S. Agent is a regulatory requirement, not a business partner. Your U.S. Agent communicates with the FDA on your behalf.​
Can I change my U.S. Agent?
Yes, but the FDA must be notified immediately through an update in your establishment registration.
What happens if I don’t appoint a U.S. Agent?​
You may not be able to complete your registration, and FDA approval or shipment entry into the U.S. could be blocked.​
Can one U.S. Agent serve multiple establishments?​
Yes, we can represent multiple facilities under one client or across different entities.​
