Global Import Agent
★★★★★
4.9
/ 5
•
14 reviews
Global Import Agent provides expert US regulatory compliance consulting for food, beverages, supplements, and cosmetics. They simplify FDA requirements, ensuring smooth market entry and ongoing compliance for international businesses.
Global Import Agent specializes in navigating complex US FDA regulations for international businesses importing food, beverages, dietary supplements, cosmetics, and medical devices. They offer comprehensive services including FDA facility registration, acting as your official US Agent, and ensuring compliance with FSVP, labeling, and import requirements. Their expertise helps prevent costly delays, detentions, and refusals by managing details like Prior Notice filing, Import Alert removal, and USDA import requirements. Whether you are a startup or a global supplier, Global Import Agent provides the regulatory guidance and hands-on support needed to expand into the US market with confidence. They are committed to simplifying import compliance, allowing clients to focus on business growth while ensuring all products meet legal and safety obligations before entering the US market.
About
**Who they are**
Global Import Agent provides expert U.S. regulatory compliance consulting for international businesses importing food, beverages, dietary supplements, cosmetics, and medical devices. They focus on simplifying FDA requirements to ensure smooth market entry and ongoing compliance.
**Expertise & scope**
* Official Appointment as FDA U.S. Agent, acting as the primary contact for U.S. regulatory bodies.
* Facility Registration & Biennial Renewal Management for FDA-regulated facilities.
* FDA Inspection Support & Communication Handling.
* Prior Notice Coordination for food, beverage, and dietary supplement shipments.
* Product Category Support & Compliance Guidance across various FDA-regulated sectors.
* Ongoing Compliance Monitoring & Updates to keep businesses informed of regulatory changes.
* FDA Detention Assistance to resolve import holds and avoid costly delays.
* Import Alert Removal Assistance to address issues leading to automatic detention.
* FSVP Agent & Assessments.
* FDA Labelling Compliance.
* USDA Import Requirements.
* US Customs Documentation & Support.
* FSMA Compliance Software.
* Low Acid Canned Food (LACF) support.
**Reputation / proof points**
* Services are available for products destined for the U.S. market.
Global Import Agent provides expert U.S. regulatory compliance consulting for international businesses importing food, beverages, dietary supplements, cosmetics, and medical devices. They focus on simplifying FDA requirements to ensure smooth market entry and ongoing compliance.
**Expertise & scope**
* Official Appointment as FDA U.S. Agent, acting as the primary contact for U.S. regulatory bodies.
* Facility Registration & Biennial Renewal Management for FDA-regulated facilities.
* FDA Inspection Support & Communication Handling.
* Prior Notice Coordination for food, beverage, and dietary supplement shipments.
* Product Category Support & Compliance Guidance across various FDA-regulated sectors.
* Ongoing Compliance Monitoring & Updates to keep businesses informed of regulatory changes.
* FDA Detention Assistance to resolve import holds and avoid costly delays.
* Import Alert Removal Assistance to address issues leading to automatic detention.
* FSVP Agent & Assessments.
* FDA Labelling Compliance.
* USDA Import Requirements.
* US Customs Documentation & Support.
* FSMA Compliance Software.
* Low Acid Canned Food (LACF) support.
**Reputation / proof points**
* Services are available for products destined for the U.S. market.
Additional information
Global Import Agent emphasizes a proactive approach to compliance, aiming to prevent issues before they arise. Their services are designed to streamline the complex process of importing FDA-regulated products into the United States. For foreign manufacturers, packers, or distributors, appointing a U.S. FDA Agent is a legal requirement under 21 CFR regulations. Failure to do so can result in incomplete registrations and refused shipments. The company offers comprehensive support, from initial facility registration and U.S. Agent appointment to managing detentions, import alerts, and ensuring ongoing adherence to evolving FDA standards. They highlight their role in facilitating seamless communication with FDA and Customs officials, preparing necessary documentation, and providing guidance on product-specific compliance.
Key Highlights
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Provides official appointment as FDA U.S. Agent, a legal requirement for foreign facilities.
Source
“all non-U.S. facilities that manufacture, process, pack, or store FDA-regulated products for U.S. distribution must appoint a U.S.-based FDA Agent.”
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Offers comprehensive support for FDA facility registration and biennial renewal management.
Source
“We handle the entire facility registration process for food, beverage, dietary supplements and cosmetics, ensuring your business complies with FDA regulations.”
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Assists with resolving FDA detentions and import alerts to ensure product release.
Source
“Our FDA Detention Assistance service helps importers quickly identify and resolve compliance issues to get products released from U.S. Customs and Border Protection (CBP) and the FDA.”
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Ensures timely and accurate FDA Prior Notice filings for imported food, beverages, and dietary supplements.
Source
“Before importing food, beverages, and dietary supplements into the United States, FDA Prior Notice must be filed to alert U.S. authorities about incoming shipments.”
Certifications & Trust Signals
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Official Appointment as FDA U.S. Agent.
Source
“Official Appointment as FDA U.S. Agent”
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Facility Registration & Biennial Renewal Management.
Source
“Facility Registration & Biennial Renewal Management”
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FDA Inspection Support & Communication Handling.
Source
“FDA Inspection Support & Communication Handling”
Buyer Snapshot
Best for
- Foreign manufacturers, packers, or distributors of FDA-regulated products
- Businesses seeking to simplify FDA import requirements
- Companies needing assistance with facility registration and U.S. Agent representation
How engagement typically works
- Consultative support for compliance needs
- End-to-end service for registration and ongoing compliance
- Proactive issue resolution for detentions and import alerts
Typical deliverables
- FDA U.S. Agent appointment
- Facility registration and renewal management
- Prior Notice filings
- Detention and import alert resolution plans
- Compliance guidance and monitoring reports
Good to know
- Best when importing food, beverages, dietary supplements, cosmetics, or medical devices into the U.S.
HQ:
Kirkcaldy, GB
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
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Registration Support:
Yes
Annual Renewal Support:
Yes
Annual Renewal Reminder:
Yes
Inspection Support:
Yes
Product Type:
food, cosmetics, devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Import Alert/Detention Resolution, Regulatory Consulting
Additional us_agent_fda Details
Product Types
Food, beverages, dietary supplements, cosmetics, medical devices
Registration Support
Yes, FDA establishment registration and device listing support is offered.
Recall Support
Assistance with FDA detention and import alert removal
Inspection Support
Yes, FDA inspection support and coordination is offered.
Emergency Contact24x7
Not explicitly stated.
US Entity State
Not specified, but they are a U.S. Agent.
Onboarding Steps
The process involves appointing Global Import Agent as the FDA U.S. Agent, facility registration, and ongoing compliance monitoring. Specific steps for each service are detailed on their respective pages.
