US Agent Pros
FDA U.S. Agent representation and compliance services for foreign FDA-regulated manufacturers, including official contact designation, registration/listing, labeling review, inspection support and product compliance.
US Agent Pros provides U.S. Agent services as required by law for foreign companies that manufacture, process, pack, or store FDA-regulated products. They manage FDA communications, assist during inspections, handle registration/listing, labeling reviews, adverse event reporting, and other compliance tasks. They serve as the official point of contact for foreign FDA-regulated manufacturers, ensuring proper communication and compliance with FDA requirements.
About
**Who they are**
US Agent Pros provides FDA U.S. Agent representation and compliance services for foreign manufacturers of FDA-regulated products. They aim to simplify market entry and ensure ongoing compliance for businesses operating in the United States.
**Expertise & scope**
* FDA U.S. Agent representation, serving as the official point of contact with the FDA for foreign entities.
* FDA registration support for facilities involved in food, drugs, and medical devices.
* Assistance with dietary supplement facility registration and renewal requirements.
* Drug establishment registration, including support for Drug Master File (DMF) submissions.
* Medical device establishment registration and device listing.
* Guidance on FDA GUDID (Global Unique Device Identification Database) compliance for medical devices.
* Preparation and procurement of FDA Export Certificates for products shipped from the U.S.
* Support for food safety compliance, including FSVP (Food Safety Preventive Controls Alliance).
* TTB (Alcohol and Tobacco Tax and Trade Bureau) compliance solutions.
**Reputation / proof points**
* Dedicated compliance professionals handle the registration process.
* Fast turnarounds are emphasized to keep products on the U.S. market without delay.
* A 100% money-back guarantee is offered for their services.
* Competitive pricing is stated as a benefit.
US Agent Pros provides FDA U.S. Agent representation and compliance services for foreign manufacturers of FDA-regulated products. They aim to simplify market entry and ensure ongoing compliance for businesses operating in the United States.
**Expertise & scope**
* FDA U.S. Agent representation, serving as the official point of contact with the FDA for foreign entities.
* FDA registration support for facilities involved in food, drugs, and medical devices.
* Assistance with dietary supplement facility registration and renewal requirements.
* Drug establishment registration, including support for Drug Master File (DMF) submissions.
* Medical device establishment registration and device listing.
* Guidance on FDA GUDID (Global Unique Device Identification Database) compliance for medical devices.
* Preparation and procurement of FDA Export Certificates for products shipped from the U.S.
* Support for food safety compliance, including FSVP (Food Safety Preventive Controls Alliance).
* TTB (Alcohol and Tobacco Tax and Trade Bureau) compliance solutions.
**Reputation / proof points**
* Dedicated compliance professionals handle the registration process.
* Fast turnarounds are emphasized to keep products on the U.S. market without delay.
* A 100% money-back guarantee is offered for their services.
* Competitive pricing is stated as a benefit.
Additional information
US Agent Pros emphasizes that appointing a U.S. Agent is a legal requirement for foreign companies manufacturing, processing, packing, or storing FDA-regulated products for the U.S. market. Without a designated U.S. Agent, facilities cannot complete FDA registration or legally ship products into the United States. They offer to serve as this official point of contact, managing critical communications and assisting with compliance matters. Their services are designed to facilitate market entry and ensure adherence to FDA regulations.
Key Highlights
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Provides FDA U.S. Agent representation, acting as the official point of contact for foreign FDA-regulated manufacturers.
Source
“Foreign companies that manufacture, process, pack, or store FDA-regulated products for the U.S. market are required by law to appoint a U.S. Agent.”
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Offers comprehensive FDA registration services for food, drugs, and medical devices.
Source
“At USAgentPros, we make FDA registration simple, fast, and worry-free — so you can focus on growing your business.”
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Assists with FDA GUDID compliance for medical devices, ensuring traceability in the U.S. market.
Source
“At USAgentPros, we help device companies meet FDA’s UDI and GUDID submission requirements quickly and accurately.”
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Provides FDA Export Certificate preparation and procurement for products leaving the U.S.
Source
“When exporting FDA-regulated products from the United States, foreign customers or governments often require an official Export Certificate.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Foreign manufacturers seeking FDA U.S. Agent representation.
- Companies needing assistance with FDA facility registration (food, drugs, medical devices).
- Businesses requiring support for GUDID and UDI compliance.
How engagement typically works
- Dedicated compliance professional assigned to each account.
- Focus on fast turnarounds and accurate handling of FDA requests.
- Offers a 100% money-back guarantee.
Typical deliverables
- Designated U.S. Agent services.
- Completed FDA facility registrations.
- FDA Export Certificates.
- GUDID submission support.
- Drug Master File (DMF) submissions.
Good to know
- Best when requiring a U.S. Agent to complete FDA registration or legally ship products to the U.S.
HQ:
United States, US
Languages:
English
Timezones:
EST, PST
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Product Type:
food, drugs, devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Export Certificate, Adverse Event Reporting (MDR/AER)
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Annual Renewal Reminder:
Yes
Additional us_agent_fda Details
Product Types
Food, Dietary Supplements, Drugs (OTC and prescription), Medical Devices, Animal Food
Registration Support
Yes, for FDA establishment registration and device listing.
Inspection Support
Mentioned as 'inspection support' in the provider description.
Onboarding Steps
The process involves appointing US Agent Pros as the U.S. Agent, which is a prerequisite for FDA registration and legal shipment of products into the U.S.
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