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

 

REGISTRATION SERVICES

 

Domestic and Foreign Companies in over 100 countries

 

FDA
REGISTRATION
SERVICES
SINCE 2009

Procurement Supply Chain starts with the FDA Registration of your company.

ITB HOLDINGS LLC can help.

  • Lowest Fees
  • Multilingual Consultants
  • Live Support Chat
  • FDA Services List below

FDA REGISTRATION SERVICES

Unlike our competitors in the United States and overseas, we offer the following services seven days a week.

FOOD

$99.00

MEDICAL DEVICES

$350.00

DRUGS

$350.00

COSMETICS

$350.00

Personal protective equipment (PPE)

Contact ITB HOLDINGS LLC before you consider importing or exporting PPEs and or Hand Sanitizers from China, Mexico, and India, because an FDA Registration is required.

We can help you get started as soon as possible.

DRUGS AND MEDICAL DEVICES IMPORT-EXPORT

Innovative drugs often mean new treatment options for patients and advances in health care for the American public.

FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application, to support a full and comprehensive assessment.

Medical devices cleared or approved by the FDA in 2023 are in the following categories:

Cataract Surgery

Spinal Implant

Dermal Filler

Prostatic Catheter

Nerve Stimulator

Lab Test

Stent

Catheter Systems

Hernia Fixation

Hemostatic System

Cardiac Catheter

Cardiac Implants

Gel Implant

Spinal Implant

Contact Lens

Glucose Monitor

Vascular Hemorrhage Blocker

Breathing Stimulator

Nerve Stimulator

Syringe Applicator

FDA REGISTRATION TRENDS

Hand Sanitizers
0%
Alcohol Wipes
0%
Face Masks
0%
N95 Respirators
0%
REGISTRATION
$350
ANNUAL
Establishment Registration
Hand Sanitizer Listing
Alcohol Wipes Listing
REGISTRATION
$350
ANNUAL
Establishment Registration
Face Masks
N95 Respirators
Medical Devices (others)
FOOD TRADE
AVOID FDA DETENTION

Register your company as Food Facility with the U.S. Food and Drug Administration (FDA).

If a manufacturer keeps physical control over the food in its storage unit, the manufacturer is holding food and is required to register the self-storage unit as a facility.

In contrast, a typical third-party logistics warehouse has sole physical control over the food stored in the warehouse. In this case the warehouse is a structure (or establishment) under one ownership at one general physical location that holds food. Therefore, the owner, operator, or agent in charge of the warehouse must register the warehouse as a facility.

Contact ITB HOLDINGS LLC, and let’s get started.

FOOD FACILITY
$99
Facility Registration
Biennial Renewal
U.S. Agent Service
Optional Certificate
SUPPLEMENT
$99
Facility Registration
Biennial Renewal
U.S. Agent Service
Optional Certificate

MORE SERVICES

Not what you are looking for?

Simply contact us.

FDA REGISTERED FACILITY OR ESTABLISHMENT
Contact ITB HOLDINGS LLC, today.