ITB Holdings LLC
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider, assisting foreign companies with FDA registration, U.S. Agent designation, and navigating complex U.S. FDA regulations for various products.
ITB Holdings LLC specializes in facilitating FDA registration and compliance for foreign companies looking to export to the United States. As an authorized U.S. Agent, they act as the primary point of contact between foreign facilities and the U.S. Food and Drug Administration, ensuring smooth communication and adherence to regulatory requirements. Their services cover a wide range of products, including Foods, Dietary Supplements, Alcoholic Beverages, Medical Devices, Drugs (Prescription and OTC), Cosmetics, and more. ITB Holdings LLC assists with crucial processes such as FDA registration, U.S. Agent designation, Prior Notice, Foreign Supplier Verification Program (FSVP), and FDA labeling compliance. With a commitment to simplifying the export process, ITB Holdings LLC helps companies expand their market reach by ensuring their facilities are registered and compliant with U.S. FDA standards. They offer expert guidance on regulatory nuances, helping clients avoid common pitfalls and maintain a strong compliance posture in the U.S. market.
About
**Who they are**
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider that assists foreign companies with FDA registration, U.S. Agent designation, and navigating U.S. FDA regulations.
**Expertise & scope**
* FDA registration for foreign establishments exporting to the United States.
* Designation as a U.S. Agent, where representations made to the FDA are considered those of the foreign facility.
* Assistance with various FDA services including Food Facility (Supplements, FCE-SID), Drugs (OTC), Medical Devices, Cosmetics, Prior Notice, FSVP, FDA Labels, and Detention.
* Guidance on FDA labeling requirements for Nutrition Facts, Supplement Facts, and Drug Facts.
* Support for FDA compliance, helping clients understand requirements, timelines, and common mistakes.
**Reputation / proof points**
* Provides Bilingual FDA Consultants, including named individuals Amanda, Simon, Sophie, and Hetty.
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider that assists foreign companies with FDA registration, U.S. Agent designation, and navigating U.S. FDA regulations.
**Expertise & scope**
* FDA registration for foreign establishments exporting to the United States.
* Designation as a U.S. Agent, where representations made to the FDA are considered those of the foreign facility.
* Assistance with various FDA services including Food Facility (Supplements, FCE-SID), Drugs (OTC), Medical Devices, Cosmetics, Prior Notice, FSVP, FDA Labels, and Detention.
* Guidance on FDA labeling requirements for Nutrition Facts, Supplement Facts, and Drug Facts.
* Support for FDA compliance, helping clients understand requirements, timelines, and common mistakes.
**Reputation / proof points**
* Provides Bilingual FDA Consultants, including named individuals Amanda, Simon, Sophie, and Hetty.
Additional information
ITB Holdings LLC emphasizes that foreign establishments exporting to the United States must designate a single U.S. Agent during the registration process. The FDA treats communications with the U.S. Agent as equivalent to direct communication with the foreign facility. While the U.S. Agent is crucial for registration and communication, they do not hold responsibility for adverse events under the Medical Device Reporting regulation. The company also offers services related to FDA labels, ensuring compliance with regulations for food, drugs, and supplements, and advises against misrepresenting FDA endorsement.
Key Highlights
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ITB Holdings LLC acts as a U.S. Agent, a mandatory requirement for foreign establishments exporting to the United States.
Source
“Foreign establishments or facilities exporting to the United States must identify an FDA U.S. Agent during the registration process.”
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The company provides FDA registration and compliance services for a range of product types including Food Facilities (Supplements, FCE-SID), Drugs (OTC), Medical Devices, and Cosmetics.
Source
“FDA Services Food Facility Supplements FCE-SID Drugs OTC Medical Devices Cosmetics”
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ITB Holdings LLC assists with FDA labeling requirements, including Nutrition Facts, Supplement Facts, and Drug Facts.
Source
“Nutrition Facts | Supplement Facts | Drug Facts”
Certifications & Trust Signals
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ITB Holdings LLC offers bilingual FDA consultants, including named individuals Amanda, Simon, Sophie, and Hetty.
Source
“Bilingual FDA Consultants Consultants Amanda Simon Sophie Hetty”
Buyer Snapshot
Best for
- Foreign companies exporting products to the U.S. requiring FDA registration.
- Businesses needing a designated U.S. Agent for FDA compliance.
How engagement typically works
- Service-based engagement for registration and compliance.
- Consultative approach to navigating FDA regulations.
Typical deliverables
- FDA Establishment Registration
- U.S. Agent Designation
- FDA Compliance Guidance
- FDA Labeling Support
Good to know
- Best when requiring a U.S. Agent for FDA registration and ongoing communication.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $99.00 - $350.00
Notes:
Based on publicly listed information; final fees depend on scope.
“Pricing: $99.00; $350.00; $99.00”
HQ:
Orlando, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Dietary supplements, Cosmetics
Portfolio:
1-5
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
Registration Support:
Yes
Time Zone Coverage:
EST
Product Type:
food
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, Import Alert/Detention Resolution, Export Certificate
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Foreign establishments must identify an FDA U.S. Agent during the registration process. Each foreign establishment may designate only one U.S. Agent.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Food Facilities (Supplements, FCE-SID), Drugs (OTC), Medical Devices, Cosmetics
Registration Support
Yes
