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 and navigating U.S. FDA regulations.
**Expertise & scope**
* Serves as the designated U.S. Agent for foreign facilities and establishments engaged in manufacturing, preparation, propagation, compounding, or processing of medical devices imported into the United States.
* Assists foreign manufacturers, repackers, relabelers, and control laboratories involved with human or veterinary drugs and human biological products, including API manufacturers.
* Provides FDA registration services for food facilities, including Food Canning Establishments (FCE) and Dietary Supplement Facilities.
* Offers assistance with FDA detention issues, helping companies whose products are refused entry by the FDA or U.S. Customs and Border Patrol.
* Supports FDA registration renewal for prescription drug and medical device establishments.
* Works with companies from over 100 countries, including Canada, Mexico, Brazil, Australia, India, Japan, China, and various European nations.
**Reputation / proof points**
* States that their Service Fees for FDA Registration are the lowest.
* Mentions specific consultants by name (Amanda, George, Helene, David) within the context of FDA Consultants.
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider that assists foreign companies with FDA registration and navigating U.S. FDA regulations.
**Expertise & scope**
* Serves as the designated U.S. Agent for foreign facilities and establishments engaged in manufacturing, preparation, propagation, compounding, or processing of medical devices imported into the United States.
* Assists foreign manufacturers, repackers, relabelers, and control laboratories involved with human or veterinary drugs and human biological products, including API manufacturers.
* Provides FDA registration services for food facilities, including Food Canning Establishments (FCE) and Dietary Supplement Facilities.
* Offers assistance with FDA detention issues, helping companies whose products are refused entry by the FDA or U.S. Customs and Border Patrol.
* Supports FDA registration renewal for prescription drug and medical device establishments.
* Works with companies from over 100 countries, including Canada, Mexico, Brazil, Australia, India, Japan, China, and various European nations.
**Reputation / proof points**
* States that their Service Fees for FDA Registration are the lowest.
* Mentions specific consultants by name (Amanda, George, Helene, David) within the context of FDA Consultants.
Additional information
ITB Holdings LLC emphasizes that foreign establishments must identify a U.S. Agent for FDA registration purposes, and the FDA will not complete registration without confirmation from the designated agent. They also note that the commercial activities of a company in the U.S. cannot be conducted through the designated U.S. Agent. The company provides services for various product categories including OTC drugs, hand sanitizers, personal protective equipment (PPE), face masks, respirators, and general medical devices. They highlight that foreign manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, processing, or testing of drugs and biological products must have a U.S. Agent. Pricing information is publicly available on their site, with specific fees listed for services like FDA registration.
Key Highlights
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ITB Holdings LLC serves as the U.S. Agent for companies from over 100 countries.
Source
“ITB HOLDINGS LLC is the U.S. Agent of companies in Canada, Mexico, Brazil, Australia, New Zealand, India, Pakistan, South Korea, Japan, China, Russia, Portugal, Greece, Italy, Spain, France, Belgium, Netherlands, Switzerland, Sweden, United Kingdom, Ireland, among more than 100 countries.”
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Assists foreign companies with FDA registration for medical devices, drugs, and biological products.
Source
“Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment.”
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Provides FDA registration services for Food Canning Establishments (FCE) and Dietary Supplement Facilities.
Source
“Food Facility Registration Food Canning Establishment (FCE) Dietary Supplement Facility Registration”
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Offers support for FDA registration renewal for prescription drug and medical device establishments.
Source
“The following domestic and foreign companies must renew their registration before December 31, 2025, regardless of when the initial registration was completed: ▪ Prescription Drug Establishment. ▪ Medical Devices Establishment.”
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ITB Holdings LLC states their Service Fees for FDA Registration are the lowest.
Source
“ITB HOLDINGS LLC’s Service Fees are the lowest for FDA Registration of your Facility or Establishment.”
Certifications & Trust Signals
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ITB Holdings LLC states their service fees are the lowest for FDA Registration.
Source
“ITB HOLDINGS LLC’s Service Fees are the lowest for FDA Registration of your Facility or Establishment.”
Buyer Snapshot
Best for
- Foreign companies needing a U.S. Agent for FDA registration.
- Manufacturers of medical devices, drugs, and biological products.
- Companies facing FDA detention or needing registration renewal.
How engagement typically works
- Service provider for FDA compliance.
- Assists with regulatory navigation.
Typical deliverables
- Designated U.S. Agent services.
- FDA Establishment Registration.
- FDA Registration Renewal.
- Assistance with FDA Detention.
Good to know
- Best when requiring a U.S. Agent for FDA compliance for imported products.
- Best when needing assistance with FDA registration and renewal processes.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $99.00 - $350.00 for various services
Notes:
Based on publicly listed information; final fees depend on scope.
“$350.00; $180.00; $99.00; $350.00; $180.00”
HQ:
Orlando, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim 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:
devices, food, cosmetics, drugs
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, Import Alert/Detention Resolution, Export Certificate
Annual Renewal Support:
Yes
Emergency Contact24x7:
Yes
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
Requires DUNS Number for registration renewal. Foreign establishments must identify a U.S. Agent for registration.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices, Drugs, Human Biological Products, Active Pharmaceutical Ingredients (APIs), Food Products (including Food Canning Establishments), Dietary Supplements, OTC Drugs, Hand Sanitizers, Personal Protective Equipment (PPE), Face Masks, Respirators.
Registration Support
Yes, for FDA establishment registration and device listing.
Inspection Support
No
Recall Support
No
Emergency Contact24x7
No
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