- No hidden costs
- No forced options
- Only what you need or want
- Reduced fee for multiple services
- Reduced fee for multiple companies
- U.S. Agent Service included
- Same Day Service for extra fee
Some registrations require additional User Fees – Medical Device Establishment and Drug Establishment. You will be informed as expected, upon request.
Are you planning on exporting these popular products to the United States?
- Live meat animals
- Fish and shellfish
- Coffee, tea and spices
- Candy and sugar
- Chocolate and cocoa
- Dietary supplements
- Medical devices
- Over-the-Counter (OTC) products.
If your response is yes, then here is your chance to expand to the U.S. market, today. But first, your company needs to register its facility or establishment with the U.S. Food and Drug Administration (U.S. FDA).
When seeking the assistance of ITB HOLDINGS LLC for the purpose of FDA Registration and or Compliance, expect two types of fees, here:
▪ Service Fees.
▪ User Fees.
Service Fees are paid to ITB HOLDINGS LLC, for the following:
Enjoy More Payment Options, here
Payment methods accepted for ITB HOLDINGS LLC’s invoices are Debit / Credit Card, Bancontact, Giropay, iDEAL, Sofort, Apple Pay, Google Pay, SEPA Direct Debit, Stripe, Payments in multiple currencies.
- Company Registration
- U.S. Agent Service
- Food Canning Establishment (FCE) Registration is not included.
FDA REGISTRATION requests must include:
- Full company name
- Complete physical address
- First and last name of CEO or Manager
- Email and telephone of CEO or Manager
- Product details
- Company DUNS Number
Data Universal Numbering System, DUNS from Dun & Bradstreet Inc. Free in 30 days.
User Fees are paid to the U.S. Treasury.
- electronic check (ACH also known as eCheck)
- credit card (Discover, VISA, MasterCard, American Express).
An FDA Payment Account is required. We can assist.
U.S. Department of Treasury
33 Liberty St
New York, NY 10045
Account Number: 75060099
Routing number: 021030004
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002
FDA’s Tax Identification Number: 53-0196965.
$6,493.00 | Medical Device Establishment Registration (FY 2023)
Over-The-Counter Monograph Drug User Fees (OMUFA) (FY 2023)
- Monograph Drug Facility (MDF) Facility Fee: $26,153
- Contract Manufacturing Organization (CMO) Facility Fee: $17,435
are now required to register an establishment manufacturing, among other products,
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- Hand Sanitizers