FDA U.S. AGENT
ITB HOLDINGS LLC AS U.S. AGENT

Although your U.S. company does not need a U.S. Agent, your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment, is required to appoint one as part of the registration process.

What a U.S. Agent is not?

  • Commercial Agent
  • Customs Broker
  • Initial Importer
  • Importer of Record
  • FSVP Importer

Our consultants serve both domestic and international clients.

FDA will not complete a registration, or provide a registration number, until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.

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
  • FDA Registration Number
  • U.S. Agent Service
$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

Annual User Fee is required and extra: $5,546.00.

$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.

User Fee is not required, at this time.

$350.00 | ANNUAL SERVICE FEE