390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
ABOUT US
U.S. FDA AGENT
FDA REGISTRATION MADE EASY AND AFFORDABLE

Our clients around the world are mostly startups, small and medium-sized enterprises (SMEs).

However, more multinationals are joining us.

  • Import-Export Companies
  • Contract Manufacturers
  • Medical Device Suppliers
  • App Developers
  • Fulfillment by Amazon Sellers
  • Warehouses
  • OTC Drug Manufacturers

We’re excited to learn about your company, and help you expand your market.

Food exporters represent the largest group of our clients because of u.s. consumers’ growing demand for tropical products, spices, and imported gourmet foods. Food companies based in the United States carry out certain processing steps offshore and import products at different levels of processing from their subsidiaries in foreign markets.

But shortages are leaving doctors, nurses and other frontline workers dangerously ill-equipped to care for COVID-19 patients, due to limited access to supplies such as gloves, medical masks, respirators, goggles, face shields, gowns, and aprons, as well as ventilators. Therefore, we expect an increase of FDA Registrations for establishments manufacturing, exporting or selling said products.

Please find here a complete list of our services.

And as always, we speak your language. See below.

CHAT WITH US IN YOUR OWN LANGUAGE
The location of your company does not determine our fees. That’s refreshing!

Just you know, we do speak more than 5 languages.

FDA REGISTRATIONS TRENDS
English
0%
French
0%
Spanish
0%
German
0%
Dutch
0%
FRENCH
FRANÇAIS
ENREGISTREMENT FDA
SPANISH
ESPAÑOL
REGISTRO FDA
DUTCH
NEDERLANDS
FDA REGISTRATIE
GERMAN
DEUTSCH
REGISTRO FDA
EXTENDED OFFICE HOURS

Monday – Sunday

3:00 AM – 6:00 PM

Eastern Standard Time

Get a faster response to your questions and concerns.

Usually same day or less than 30 minutes if you provide full company name, physical address and telephone number.

T: +44 800 610 1577

MOSTLY REQUESTED FDA REGISTRATIONS
Food Facility Registration
0%
Dietary Supplements Facility
0%
Cosmetic Establishment (OTC)
0%
Drug Establishment
0%
Medical Device Establishment
0%
Food Canning Establishment
0%
LIMITED OFFER
FOOD FACILITY REGISTRATION
Available for Biennial Renewal of 2020 or New Registration.
$99.00 | ANNUAL SERVICE FEE
PERSONAL PROTECTIVE EQUIPMENT
(PPE)

The global personal protective equipment (PPE) market is expected to reach nearly $13.2 billion by 2027.

Is your company manufacturing, exporting, importing, distributing the following products, instead?

  • Facemasks
  • N95 Respirators and Surgical Masks
  • Face shields, isolation gowns, goggles, gloves

The FDA Registration of your establishment is required, and ITB HOLDINGS LLC can assist.

$350.00 | ANNUAL SERVICE FEE
HAND SANITIZERS

Global Hand sanitizer market valuation to reach $17.2 billion by 2026.

The growth is primarily attributed to rising prevalence of COVID-19, supportive regulatory scenario which promote the use of the product, and increasing awareness pertaining to personal hygiene.

Are you ready to meet the supply challenge?

Your first step is the registration of your company as OTC Drug Establishment with the U.S. Food and Drug Administration.

ITB HOLDINGS LLC offers assistance to domestic and foreign firms.

$350.00 | ANNUAL SERVICE FEE