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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA

 

REGISTRATION

 

Compliance Services for Food, Dietary Supplements, Cosmetics, Drugs and Medical Devices Establishments

 

FDA Compliance Services



Fast, Secure Payments for Your FDA Consultant Service Fees


Professional support for domestic companies, as well as foreign manufacturers and exporters shipping food, dietary supplements, cosmetics, drugs, over-the-counter products and medical devices to the United States.

Service Fees compensate an independent FDA Consultant for regulatory assistance. They are separate from any government user fees, customs charges, laboratory costs or third-party expenses that may apply.


Professional FDA compliance consulting and service fee payment support
Clear scope. Pricing Transparency. Professional support. Select the service that matches your product, establishment and U.S. market-entry needs.

What Your Service Fee May Cover

The exact scope depends on the service selected, your product category, the number of establishments and products, and the regulatory work required.


01

Registration & Renewal

Assistance with establishment registration, listing, updates, annual renewals and biennial renewals, where applicable.

02

Representation

U.S. Agent, FSVP-related support, Initial Importer coordination and communication assistance for eligible foreign companies.

03

Label & Packaging Review

Regulatory review of labels, claims, ingredient statements, required panels issues.

04

Compliance Guidance

Practical guidance regarding documentation, inspections, import readiness, product classification and risks.

FDA-Regulated Product Categories


Food Supplements Cosmetics Drugs Medical Devices

Flexible Payment Options

Debit or credit card, Apple Pay, Google Pay, SEPA Direct Debit, Stripe-supported local methods, multiple currencies and PayPal.

Ready to Move Forward?

Review the available FDA compliance services, confirm the scope, and complete payment through the secure service page.

》 Pay Service Fees
SAVE TIME & MONEY
Days
Hours
Minutes
Seconds
FOOD COMPANIES
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Food Facility Registration
On Sale
Original price was: $300.00.Current price is: $180.00.
Food Label Review
$150.00
FSVP
$350.00
Prior Notice
$25.00
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Biennial Food Facility Registration (FFR) Renewal
On Sale
Original price was: $300.00.Current price is: $180.00.
Canned Food
$350.00
Food Facility Registration & FSVP
On Sale
Original price was: $880.00.Current price is: $590.00.
Registration & FDA Certificate
On Sale
Original price was: $399.00.Current price is: $270.00.
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COSMETIC COMPANIES
DRUG COMPANIES
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MEDICAL DEVICE COMPANIES
OTHER SERVICES
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FEI Search
$150.00
Label Update
$150.00
Packaging Review
$150.00
Toll Free Number
$350.00
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Global U.S. FDA Advisory Services

 

Extended U.S. FDA Compliance Consulting

Regulatory support for domestic and foreign manufacturers, exporters, importers and distributors navigating U.S. FDA requirements for food, dietary supplements, cosmetics, pharmaceuticals and medical devices.

 

U.S. Market Entry Registration, listing, importer and regulatory support for companies entering the United States.
FDA Compliance Practical assistance with documentation, labeling, inspections, import requirements and regulatory deficiencies.
Global Support Compliance consulting for manufacturers and exporters throughout Asia, Africa, Latin America and Europe.

Serving Manufacturers & Exporters Worldwide

U.S. FDA compliance requirements can vary significantly according to product category, establishment activity, importer structure and country of manufacture. Our consulting services help companies identify and address the requirements applicable to their U.S. operations.

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Asia

FDA establishment registration, Initial Importer support, product listing, labeling review, food facility registration, FSVP guidance, regulatory documentation and pre-inspection preparation for manufacturers and exporters throughout Asia.

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Africa

Food facility registration, FSMA and FSVP compliance, dietary supplement labeling, U.S. Agent support, import documentation, detention assistance and regulatory consulting for African manufacturers exporting FDA-regulated products.

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Latin America

FDA registration and listing, medical device compliance, food-import requirements, FSVP support, labeling review, U.S. Agent services and regulatory consulting for manufacturers and exporters throughout Latin America.

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Europe

Regulatory strategies for European companies adapting existing compliance programs to U.S. FDA requirements, including medical devices, pharmaceuticals, food, cosmetics and dietary supplements.

Extended FDA Compliance Capabilities

 

Support can be tailored to the product, establishment and stage of U.S. market entry.

FDA Facility Registration Registration, renewal and establishment information support for FDA-regulated facilities.
U.S. Agent Services United States-based regulatory communication support for qualifying foreign establishments.
FSVP Compliance Foreign Supplier Verification Program assistance for food products imported into the United States.
Initial Importer Services Regulatory support for foreign medical device manufacturers requiring an Initial Importer in the United States.
Label & Claims Review Review of food, dietary supplement, cosmetic, drug and medical device labeling for applicable U.S. requirements.
FDA Detention Assistance Assistance responding to FDA holds, detention notices, import compliance issues and supporting documentation requests.
Inspection Readiness Documentation review, mock inspection preparation and compliance support before an FDA inspection.
Medical Device Compliance Establishment registration, device listing, importer requirements and market-entry regulatory consulting.
U.S. Import Compliance Assistance coordinating FDA regulatory requirements with import, customs and supply-chain considerations.
U.S. FDA regulatory compliance consulting for domestic and foreign manufacturers
U.S. FDA Compliance Support

 

Preparing to Manufacture, Export or Sell FDA-Regulated Products in the United States?

 

Explore extended U.S. FDA compliance services designed for domestic businesses and foreign manufacturers, exporters, importers and distributors operating across food, dietary supplements, cosmetics, pharmaceuticals and medical devices.

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QUESTIONS?
Use the Live Support Chat, 24/7, including in foreign languages.

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