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FDA

 

U.S. AGENT

 

 

Your company is required to appoint one as part of the registration process

 

 

ITB HOLDINGS LLC
YOUR COMPANY’S 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, such as ITB HOLDINGS LLC, 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.

Additionally, because U.S. Agents would have direct access to a list of facilities identifying them as U.S. Agent, the identification system will limit the number of unauthorized and or fraudulent U.S. Agent listings.

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%

日本企業は ITB HOLDINGS LLC を FDA の米国代理人として推薦しています。


La registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti. Più di 10.026 aziende alimentari italiane sono registrate presso la Food and Drug Administration (FDA) degli Stati Uniti.


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%

REGISTER YOUR FOOD FACILITY

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FSVP
$350.00
Prior Notice
$25.00
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MEDICAL DEVICES

The global medical devices market is expected to reach nearly $718.9 billion by 2029.

Is your company manufacturing, exporting, importing, distributing the following products or other medical devices?

  • Facemasks
  • N95 Respirators and Surgical Masks
  • Face shields, isolation gowns, goggles, gloves
  • All other medical devices

Including:

Manual wheelchairs or electric wheelchairs.
Hospital beds.
Walkers, crutches, canes.
Pressure mattresses.
Insulin pumps.
Breast pumps.
Nebulizers.
Powered toothbrushes.
Condoms.
Bandages.
Menstrual tampons and pads.
Dental instruments.
Sunglasses.
Medical Apps.
Software as a Medical Device (SaMD).

The following establishments must be registered with the U.S. Food and Drug Administration:

Annual User Fee is not included: $7,653.

$350.00 | ANNUAL SERVICE FEE
OVER-THE-COUNTER DRUG PRODUCTS

Global Over-the-Counter (OTC) drugs market valuation to reach $233.6 billion by 2028.

Are you ready to meet the supply challenge for the following?

Sunscreen

Antidandruff shampoo

Toothpaste containing fluoride

Antiperspirant deodorant

Cold and cough products

Laxative

Skin protectant

Vaginal contraceptive

Weight control

Hand sanitizers.

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

User Fees of $17,435 – $26,153 are required, at this time.

$350.00 | ANNUAL SERVICE FEE
CONTACT ITB HOLDINGS LLC
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