FDA Agent Pro

FDA Agent Pro LLC
Verified

FDAAgentPro provides expert U.S. FDA Agent, Registration, Export Certificate, and FSVP Agent services for foreign and domestic companies.

FDAAgentPro specializes in comprehensive FDA compliance solutions for businesses worldwide. We offer professional U.S. Agent representation, ensuring seamless communication and adherence to FDA requirements for foreign facilities. Our services include FDA Registration for food, drug, cosmetic, and medical device facilities, including MoCRA Act compliance. We also provide FDA Export Certificate services tailored to specific industries and product categories, facilitating international trade. For food importers, our FSVP Agent services ensure compliance with U.S. food safety standards by managing supplier verification, record-keeping, and communication with the FDA. FDAAgentPro is your trusted partner for navigating complex FDA regulations and maintaining operational integrity.

About

**Who they are**
FDAAgentPro provides expert U.S. FDA Agent, Registration, Export Certificate, and FSVP Agent services for foreign and domestic companies, ensuring compliance with FDA regulations for food, drugs, cosmetics, and medical devices.

**Expertise & scope**
* **U.S. Agent Services:** Acts as the official U.S. Agent for foreign facilities, facilitating communication and addressing FDA inquiries.
* **FDA Registration:** Assists with preparing and submitting FDA facility registrations, managing renewals, and ensuring accuracy of facility details.
* **FDA Export Certificates:** Tailors export certificates for various industries including food and beverages, pharmaceuticals, medical devices, cosmetics, and veterinary products.
* **FSVP Agent Services:** Manages supplier compliance, record-keeping, and communication with the FDA for U.S. importers, conducting supplier compliance assessments.
* **Product Coverage:** Supports compliance for food, drugs, cosmetics, and medical devices.

**Reputation / proof points**
* Based in San Diego, California.

Additional information

FDAAgentPro offers a suite of services designed to navigate complex FDA regulations. For foreign facilities, appointing a U.S. Agent is a mandatory requirement for FDA communication. FDAAgentPro fulfills this role by acting as the official point of contact, handling inquiries, and providing automatic reminders for renewal deadlines. Their FSVP Agent services are crucial for U.S. importers needing to verify foreign supplier compliance with FDA safety standards, including conducting necessary product assessments and managing ongoing monitoring. The company also provides FDA Export Certificates tailored to specific product categories and assists with FDA facility registrations and renewals.

Key Highlights

  • Provides expert U.S. FDA Agent, Registration, Export Certificate, and FSVP Agent services. Source
    “FDAAgentPro provides expert U.S. FDA Agent, Registration, Export Certificate, and FSVP Agent services for foreign and domestic companies.”
  • Ensures compliance with FDA regulations for food, drugs, cosmetics, and medical devices. Source
    “Ensure compliance with FDA regulations for food, drugs, cosmetics, and medical devices.”
  • Offers tailored FDA Export Certificates for various industries including food, pharmaceuticals, medical devices, cosmetics, and veterinary products. Source
    “The FDA export certificates are tailored to each industry and supply specific information for different product categories.”
  • Acts as an official U.S. Agent for foreign facilities, managing communication and inquiries 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.”
  • Provides FSVP Agent services to manage supplier compliance and communication with the FDA for U.S. importers. Source
    “We act as your official FSVP Agent, managing supplier compliance, record-keeping, and communication with the FDA.”

Certifications & Trust Signals

  • 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
  • Companies requiring FDA registration and renewal support
  • Importers needing FSVP Agent services
  • Businesses seeking FDA Export Certificates
How engagement typically works
  • Acts as official representative
  • Manages communication with FDA
  • Handles inquiries and issues
  • Provides compliance assessments
Typical deliverables
  • U.S. Agent representation
  • FDA facility registration submission
  • FDA Export Certificates
  • FSVP compliance reports
  • Renewal reminders
Good to know
  • Best when requiring specialized FDA compliance support for food, drugs, cosmetics, and medical devices.

Pricing

Model: Custom pricing
Public range: Publicly listed: $100 - $299 for Export Certificates; $269 - $299 per year for U.S. Agent services.
Notes: Pricing for FDA Export Certificates varies by product type ($100-$175). U.S. Agent services are listed at $269-$299 per year.
“$175; $155; $100; $175; $155”
HQ: San Diego, US
Website: fdaagentpro.com
Public email: info@fdaagentpro.com
Phone: +1 619-410-3883
Languages: English, Spanish
Timezones: America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Access: Verified
Claim status: Claimed

Services & Capabilities

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Jurisdictions: US, UK, CH, EU, Global, AU, JP, BR
Countries: US, Canada, China, United Kingdom, Germany, Mexico, France, Italy, Spain, Netherlands, Belgium, Switzerland, Sweden, Norway, Finland, Poland, Ireland, Portugal, Greece, Argentina, Romania, Japan, Australia, India, Singapore, South Korea, Brazil, United Arab Emirates, New Zealand, Austria, Denmark, Czech Republic, South Africa, United States, Israel
Industries: Foods, Beverages, Dietary supplements, Cosmetics, Medical Devices
Portfolio: 1-5, 6-25, 26-100
Response SLA: 48 hours
Onboarding time: 1–10 days
Pricing model: Custom pricing
Starting from: USD 299
Included services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Product Type: food, devices, drugs, cosmetics
Annual Renewal Support: Yes
Registration Support: Yes
Recall Support: No
Time Zone Coverage: US Pacific, US Eastern, US Mountain, GMT, US Central, CET, CEST, JST, AEST, BRT
Inspection Support: No
Emergency Contact24x7: Yes
Annual Renewal Reminder: Yes
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