FDA Agent Pro
FDA Agent Pro provides services for FDA-regulated industries, including facility registration, product listing, and export certifications. They facilitate submissions to the U.S. Food and Drug Administration.
FDA Agent Pro is a specialized service catering to businesses within FDA-regulated sectors. They offer comprehensive support for essential administrative processes, including facility registrations, product listings, and the generation of export certifications. Their expertise ensures smooth and compliant submissions to the U.S. Food and Drug Administration (FDA), leveraging systems designed to manage critical information for food, biologics, drugs, medical devices, and more. The FDA Industry Systems (FIS) platform, which FDA Agent Pro utilizes, has been operational since October 16, 2003, providing 24/7 access for industry submissions. This system was partly developed in response to the Bioterrorism Act of 2002, emphasizing the importance of robust information management for public health and safety. FDA Agent Pro helps clients navigate these requirements, ensuring adherence to regulations for food facility registration and prior notice for imported food products.
About
**Who they are**
FDA Agent Pro is a service provider specializing in FDA compliance for companies operating in FDA-regulated industries. They are based in San Diego, California.
**Expertise & scope**
* Facilitates submissions to the U.S. Food and Drug Administration.
* Provides services including facility registration, product listing, and export certifications.
* Offers U.S. Agent representation for foreign facilities, acting as an official contact with the FDA and addressing inquiries.
* Manages renewals for facility registrations and provides automatic reminders.
* Assists with FDA export certificates tailored to specific product categories such as food and beverages, pharmaceuticals, medical devices, cosmetics, and veterinary products.
* Acts as a U.S.-based FSVP (Food Safety Modernization Act) Agent for foreign suppliers shipping food products to the U.S., managing compliance, record-keeping, and communication with the FDA.
* Conducts supplier compliance assessments to ensure imported products meet U.S. regulations.
**Reputation / proof points**
* Based in San Diego, California.
FDA Agent Pro is a service provider specializing in FDA compliance for companies operating in FDA-regulated industries. They are based in San Diego, California.
**Expertise & scope**
* Facilitates submissions to the U.S. Food and Drug Administration.
* Provides services including facility registration, product listing, and export certifications.
* Offers U.S. Agent representation for foreign facilities, acting as an official contact with the FDA and addressing inquiries.
* Manages renewals for facility registrations and provides automatic reminders.
* Assists with FDA export certificates tailored to specific product categories such as food and beverages, pharmaceuticals, medical devices, cosmetics, and veterinary products.
* Acts as a U.S.-based FSVP (Food Safety Modernization Act) Agent for foreign suppliers shipping food products to the U.S., managing compliance, record-keeping, and communication with the FDA.
* Conducts supplier compliance assessments to ensure imported products meet U.S. regulations.
**Reputation / proof points**
* Based in San Diego, California.
Additional information
FDA Agent Pro offers comprehensive support for foreign entities needing to comply with U.S. FDA regulations. Their services are designed to streamline the process of engaging with the FDA, particularly for those requiring a U.S. Agent or FSVP Agent. They emphasize facilitating communication and ensuring accuracy in submissions to avoid delays. For export certificates, they cater to various product types, issuing documentation relevant to specific FDA centers. Their FSVP agent services include managing supplier verification and compliance with FDA safety standards for imported foods.
Key Highlights
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Provides U.S. Agent services for foreign facilities to act as an official contact with the FDA.
Source
“If you are a foreign facility, you must appoint a U.S. Agent to act as your official contact with the FDA.”
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Offers FDA Export Certificates for various product categories including food, pharmaceuticals, medical devices, cosmetics, and veterinary products.
Source
“Food and Beverages: Includes conventional foods, dietary supplements, and ingredients. Pharmaceuticals: Encompasses both prescription and OTC drugs.”
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Acts as a U.S.-based FSVP Agent for foreign suppliers shipping food products to the U.S.
Source
“If you are a foreign supplier shipping food products to the U.S., you must designate a U.S.-based FSVP Agent to represent you.”
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Facilitates FDA facility registration and manages renewals.
Source
“Preparing and submitting your FDA facility registration Managing renewals during the biennial renewal period”
Certifications & Trust Signals
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Based in the vibrant heart of San Diego, California.
Source
“Based in the vibrant heart of San Diego, California”
Buyer Snapshot
Best for
- Foreign companies needing a U.S. Agent
- Exporters requiring FDA certificates
- Food importers needing FSVP representation
How engagement typically works
- Official FDA communication channel
- Compliance management
- Record-keeping and reporting
Typical deliverables
- U.S. Agent services
- FDA Registration support
- FDA Export Certificates
- FSVP Agent services
- Supplier compliance assessments
Good to know
- Best when engaging with U.S. FDA regulations for the first time or seeking dedicated representation.
Pricing
Model:
Custom pricing
HQ:
United States, US
Languages:
English
Timezones:
EST, PST, CST
Status:
claimed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD
Response SLA:
48 hours
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Registration Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Export Certificate
Additional us_agent_fda Details
Product Types
Food, Dietary Supplements, Drugs, Medical Devices, Cosmetics, Veterinary Products
Registration Support
Yes
Recall Support
No explicit mention found.
Inspection Support
Support for FDA inspections and enforcement actions (related to FSVP)
Emergency Contact24x7
No explicit mention found.
US Entity State
California
Onboarding Steps
No explicit mention found regarding specific onboarding steps, required documents, or timelines.
