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 focus on facilitating market entry and ongoing compliance for businesses expanding into the United States.
**Expertise & scope**
* Official contact designation with the FDA.
* Assistance with FDA facility registration and listing requirements for food, drugs, and medical devices.
* Support for Drug Master File (DMF) submissions.
* Guidance on FDA GUDID (Global Unique Device Identification Database) compliance for medical devices.
* Services related to FDA Export Certificates.
* Labeling review and product compliance.
* Inspection support.
* TTB Compliance Solutions and GACC Registration.
**Reputation / proof points**
* Serves as the official point of contact with FDA for foreign companies.
* Ensures critical communications are received and compliance is assisted.
* Facilitates FDA registration and legal shipment of products into the United States.
US Agent Pros provides FDA U.S. Agent representation and compliance services for foreign manufacturers of FDA-regulated products. They focus on facilitating market entry and ongoing compliance for businesses expanding into the United States.
**Expertise & scope**
* Official contact designation with the FDA.
* Assistance with FDA facility registration and listing requirements for food, drugs, and medical devices.
* Support for Drug Master File (DMF) submissions.
* Guidance on FDA GUDID (Global Unique Device Identification Database) compliance for medical devices.
* Services related to FDA Export Certificates.
* Labeling review and product compliance.
* Inspection support.
* TTB Compliance Solutions and GACC Registration.
**Reputation / proof points**
* Serves as the official point of contact with FDA for foreign companies.
* Ensures critical communications are received and compliance is assisted.
* Facilitates FDA registration and legal shipment of products into the United States.
Additional information
US Agent Pros emphasizes a streamlined process for FDA compliance, aiming to make FDA registration simple, fast, and worry-free. They highlight their role in helping companies avoid costly mistakes and delays. For food and dietary supplement facilities, registration is required before shipping products into the U.S. and must be renewed every even-numbered year. Medical device establishments must register before selling in the U.S. and may also need to list their devices. Foreign companies are legally required to appoint a U.S. Agent to act as the official point of contact with the FDA.
Key Highlights
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Provides FDA U.S. Agent representation and compliance services 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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Facilitates FDA registration for food, drugs, and medical devices, including renewal processes.
Source
“The U.S. Food and Drug Administration (FDA) requires thousands of companies each year to register before selling their products in the world’s most competitive market.”
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Offers support for Drug Master File (DMF) submissions and FDA GUDID compliance.
Source
“Drug Master File (DMF) Preparation & Submission”
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Assists with obtaining FDA Export Certificates for products being shipped from the United States.
Source
“When exporting FDA-regulated products from the United States, foreign customers or governments often require an official Export Certificate.”
Certifications & Trust Signals
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Acts as the official point of contact with FDA, receiving critical communications and assisting with compliance.
Source
“This agent serves as the official point of contact with FDA, receiving critical communications and assisting with compliance.”
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Ensures companies can complete FDA registration and legally ship products into the United States.
Source
“Without a designated U.S. Agent, your facility cannot complete FDA registration or legally ship products into the United States.”
Buyer Snapshot
Best for
- Foreign manufacturers seeking FDA representation.
- Companies needing assistance with FDA registration for food, drugs, or medical devices.
- Businesses requiring a U.S. Agent for compliance.
How engagement typically works
- Dedicated compliance professional assigned to accounts.
- Focus on fast turnarounds and accurate handling of FDA requests.
Typical deliverables
- Official U.S. Agent designation.
- Completed FDA facility registrations.
- Drug Master File (DMF) submissions.
- GUDID compliance support.
- FDA Export Certificates.
Good to know
- Best when a foreign entity needs to comply with U.S. FDA regulations for market entry.
HQ:
United States, US
Languages:
English
Timezones:
EST, PST
Status:
listed
Services & Capabilities
Best 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:
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)
Additional us_agent_fda Details
Product Types
Food, Dietary Supplements, Drugs (OTC and prescription), Medical Devices, Animal Food
Registration Support
Yes, FDA establishment registration and device listing support is offered.
Inspection Support
Yes, inspection support is mentioned.
Onboarding Steps
The process involves appointing USAgentPros as the FDA U.S. Agent, which is a prerequisite for FDA registration and shipping products into the U.S. They handle FDA requests quickly and accurately.
