Trusted U.S. Agent Services for FDA Registration
Ensure seamless market access with our U.S. Agent for FDA registration services. We handle all aspects of FDA communication and compliance, offering you peace of mind and uninterrupted operations. Appointing Axentra Global ensures your facility meets all regulatory requirements efficiently. Trust us as your U.S. Agent for FDA registration to simplify compliance and secure your business success.
Who Needs a U.S. Agent?
Designating a U.S. Agent is mandatory under federal law (21 CFR) for all foreign facilities that manufacture, process, pack, or hold FDA-regulated products. You cannot legally register your facility without one.
We Serve :
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Pharmaceutical Manufacturers (API, FDF, OTC, Clinical Trial Materials)
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Medical Device
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Dietary Supplement Manufacturers
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Cosmetic Manufacturers & Brand Owners (Under MoCRA)
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Food & Beverage Facilities
The Reality: If your manufacturing site is outside the United States, you cannot register with the FDA or ship a single unit to the U.S. without a registered U.S. Agent.
What the FDA Expects from Your Agent
The FDA does not view the U.S. Agent as a formality; they view us as you. Under the law, providing information to your U.S. Agent is legally equivalent to providing it to your foreign facility.
The FDA expects Axentra to:
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Be Reachable 24/7: Answer the phone during U.S. business hours (Eastern Time) for emergency communications.
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Facilitate Inspections: Coordinate travel, scheduling, and logistics for FDA investigators visiting your foreign plant.
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Respond Instantly: FDA deadlines are tight. A 24-hour delay in responding to a detention notice can cost you thousands in storage fees.
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Maintain Data Accuracy: Ensure your DUNS number, facility address, and product listings are 100% accurate to prevent registration cancellation.
Risk of a "Passive Agent"
Many foreign companies choose the cheapest U.S. Agent they can find. This is a critical business error. A non-responsive agent is treated by the FDA as a compliance risk, not a clerical issue.
Consequences of a "Ghost" Agent:
1
FDA Emails - Unanswered
Resulting in immediate facility registration cancellation
2
Import Detentions
Shipments held at U.S. Customs because the agent did not confirm "Prior Notice."
3
Missed Inspection Notices
If the FDA tries to schedule an inspection and your agent misses the email, your facility goes on Import Alert (Red List).
4
Costly Delays
Communication lags that result in weeks of lost sales.
The Axentra Difference
We are not a "Name-on-Paper" Agent. We operate as your active U.S. Compliance Office. We protect your market access
Our Service Guarantee:
Active Liability Shield
We review FDA communications before forwarding them to you, adding our expert analysis on how to respond.
Zero Outsourcing
We do not farm out this responsibility. Your U.S. Agent is Axentra Global, based in New Mexico, USA
Compliance Dashboard
We maintain clean, traceable documentation of all FDA interactions.
No Surprises
You will never miss an FDA notice, inspection request, or registration renewal deadline.