ITB HOLDINGS LLC

Just image having your own FDA Compliance Department for the fraction of the cost! No salary or bonus to pay.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.itbhdg.com/consultants/

Foreign Supplier Verification Program (FSVP) and Food Safety Systems Recognition Arrangements (SRA):

Currently, Canada, Australia and New Zealand, are the only countries that have signed SRA with the FDA, for the purpose of Foreign Supplier Verification Program (FSVP).

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.fda.itbhdg.com/fsvp/

Il servizio di registrazione FDA (Agenzia per gli Alimenti e i Medicinali) più economico e veloce sul mercato! Aiutiamo le aziende alimentari a conformarsi alle normative FDA degli Stati Uniti in modo rapido e corretto.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.fda.itbhdg.com/registrazione-fda/

When shipping your products to a U.S. Amazon warehouse, don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, United Kingdom, are the same or similar.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.fda.itbhdg.com/blog/fulfillment-by-amazon-fba/

THANKSGIVING, BLACK FRIDAY, SMALL BIZ SATURDAY, CYBER MONDAY SALES start today.

Your company is based in China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Spain | Italy | Netherlands | Belgium | Switzerland | Sweden | Denmark | Australia | New Zealand | Ireland | Poland | Russia | India | Czech Republic | Brazil | United States.


REGISTER YOUR COMPANY WITH THE FDA, TODAY | SAVE UP TO 75%

* FOOD COMPANY

* DIETARY SUPPLEMENTS COMPANY

* FOOD CANNING COMPANY

* MEDICAL DEVICES COMPANY

* DRUGS COMPANY

* COSMETICS COMPANY


Avoid costly Detention Without Physical Examination (DWPE) by the FDA.

Is your company on FDA's Green List or Red List?

CONTACT US NOW | M - S | 3:00 AM - 6:00 PM EST (Eastern Standard Time)

Make sure you have your company's DUNS Number ready.

Live Support Chat, seven days a week.

EXTENDED OFFICE HOURS : 3:00 AM - 6:00 AM Eastern Standard Time - EST | Multilingual and International Team to handle your requests within hours, not days.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
USA

T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype : itbholdings

https://www.itbhdg.com | https://www.m.itbhdg.com | https://www.fda.itbhdg.com | https://www.itbholdingsllc.com

ITB HOLDINGS LLC
is recommended by clients in Ireland, United Kingdom, Netherlands, Belgium, Denmark, Switzerland, Germany, France, Italy, Spain, Portugal, Sweden, Russia, South Korea, Japan, China, Hong Kong, Taiwan, Indonesia, India, Pakistan, Australia, New Zealand, Brazil, Mexico, Canada, USA.

Food Facility Registration: $99.00
Supplement Facility Registration: $99.00
Food Canning Establishment (FCE) Registration: $350.00
Medical Device Establishment Registration: $350.00
Drug Establishment Registration: $350.00
Cosmetics Establishment (OTC) Registration: $350.00


ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 510 2240
T: +1 855 389 7344
T: +44 800 610 1577
itbholdings | Skype
info@itbhdg.com

Live Support Chat

Monday - Sunday

https://www.itbhdg.com | http://www.m.itbhdg.com | https://www.fda.itbhdg.com | https://www.itbholdingsllc.com

If your company is shipping / exporting food and dietary supplements to the United States, you may want to contact us, first.

FDA FOOD FACILITY REGISTRATION
$99.00 | Annual Service Fee


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

T: +1 855 510 2240
T: +1 855 389 7344
T: +44 800 610 1577
itbholdings | Skype
info@itbhdg.com

Live Support Chat
Monday - Sunday
3:00 AM - 6:00 PM
Eastern Standard Time

https://www.itbhdg.com | http://www.m.itbhdg.com | https://www.fda.itbhdg.com | https://www.itbholdingsllc.com

MEDICAL DEVICES | PREMARKET NOTIFICATION 510(K) | PREMARKET APPROVAL (PMA) | ESTABLISHMENT REGISTRATION

Establishment Registration + U.S. Agent

Registration of your facility, changes, updates and cancellations as needed at no extra cost.
Assistance with FDA Medical Device Fee payment per FDA's requirements.

Medical Device Listing

Assistance in determining your device's likely classification.
Device listing with the FDA, changes, updates and cancellations as needed.

REQUIRED INFORMATION : â–  Full company's name (as registered locally) â–  Street address, city, postal / zip code, state, country â–  Full name of CEO / Manager â–  Telephone number of CEO / Manager â–  Email of CEO / Manager â–  Product details.

Premarket Notification 510(k)

One of the first steps for medical device companies that manufacture Class II medical devices (and a small number of Class I devices) is to file a Premarket Notification, also known as a FDA 510(k) submission, with the FDA.

We evaluate the classification of your medical device and determine the proper FDA product code and regulation number.
We determine which similar (predicate) devices already have FDA 510(k) clearance and whether they are suitable for use in your 510(k) submission.

Prepare all 21 sections of the FDA 510(k) application.
Coordinate your payment of FDA 510(k) submission fees on your behalf.
Submit the 510(k) to the FDA and answer follow-up questions from the FDA reviewer.
Upon clearance of your device, we register your establishment with the FDA.

Administrative Review and Submission Service do not include an evaluation of your science, data or technology.

FDA COMPLIANCE

Offering an article that is a drug or medical device for import without establishment registration, is illegal.

Even when a Premarket Notification 510(k) is not required, it is necessary to meet other requirements including registration of the establishment, listing of medical devices made there, labeling and Good Manufacturing Practices (GMP)'s.

Drug and medical device establishment registration must be completed annually.

CONTACT US TODAY | SAVE TIME & MONEY

Live Support Chat, Fast Email Responses | T : +1 855 510 2240 | T : +1 855 389 7344 | T : +44 800 610 1577 | Skype : itbholdings | 3:00 AM - 6:00 PM Eastern Standard Time | https://www.itbhdg.com | http://www.m.itbhdg.com | https://www.fda.itbhdg.com | https://www.itbholdingsllc.com

ONLY IF YOU KNOW OR SPEAK SPANISH

Los centros nacionales y extranjeros que produzcan, procesen, envasen o almacenen alimentos para consumo humano o animal en los Estados Unidos, deben registrarse ante la FDA (Administración de Alimentos y Medicamentos)

Alimentos INCLUIDOS
• Suplementos e ingredientes dietéticos
• Fórmula para infantes
• Bebidas (incluyendo bebidas alcohólicas y agua embotellada)
• Frutas y hortalizas
• Pescados y mariscos
• Productos lácteos y huevos
• Productos agrícolas crudos para usar como
alimentos o componentes de alimentos
• Alimentos enlatados y congelados
• Productos de panadería, bocadillos y dulces (incluyendo goma de mascar)
• Animales vivos para el consumo
• Alimentación animal y comida para mascotas

Teléfono de contacto :
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Dirección de correo : info@itbhdg.com
skype : itbholdings
Exclusivamente para la consultas de productos o servicios
Horario de atención :
De Lunes a Domingo de 3h30 a 18h00

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