B2B TradeCenter helps foreign companies comply with the United States Food and Drug Administration (FDA)

The B2B TradeCenter is a unit of the leading online B2B portal in the Americas (operating B2USA, B2Brazil and B2Argentina) that promotes trade among nearly 150,000 registered companies. We have our offices in Miami, Florida, USA, as well as Sao Paulo, Brazil. We provide complete commercial solutions for companies that include FDA compliance services for the following industries:

  • Food and Beverage;
  • Medical Equipment;
  • Drugs;
  • Cosmetics.

Our team includes FDA specialists, lawyers and consultants in the United States. In addition, the B2B TradeCenter helps companies meet the requirements of USDA (food) and TTB (alcohol). The B2B TradeCenter is not affiliated with the US FDA, USDA or TTB. Our services are always provided at fair and competitive rates.

The B2B TradeCenter is your trusted partner, and unlike any other option for FDA compliance services.

Why the B2B TradeCenter ?

Differential
Most FDA service providers
B2B TradeCenter
Offers complete solutions for Foreign Trade? Does not offer Yes, as part of the largest B2B portal network in the Americas
With an office in the USA? Some yes, some no Yes, we are located in Miami, Florida
Price Medium / high variable and fixed cost Low fixed cost

WE HAVE A COMMERCIAL TEAM SPECIALIZED IN INTERNATIONAL TRADE AND BUSINESS

THE BEST SERVICES AND PRICING OFFERS FOR YOUR COMPANY!

Food and Beverages

The FDA regulates food, beverages and dietary supplements intended for human or animal consumption within the United States of America. The B2B TradeCenter provides registration, agency and regulatory compliance assistance from the USA for US and foreign companies in the food, beverage and dietary supplements segments.

In addition, the B2B TradeCenter helps companies meet the requirements of USDA (food) and TTB (alcohol). See on the side what our services include.

FDA registration is required for all facilities that manufacture, process, pack or store food, beverages or dietary supplements that can be consumed in the United States by humans and / or animals. Foreign companies must designate a US-based agent for communications with the FDA.

Prior Notice confirmation is required before importing food shipments to the US.

We translate, review and adapt food labels, beverages or nutritional supplements to comply with FDA regulations. Our report identifies relevant standards, compliance guides, warning letters, import alerts and other guidance documents.


Medicines

The FDA regulates medications intended for the use of diagnosis, cure, mitigation, treatment or prevention of diseases and that affect the structure or any function of the body of humans or animals. The B2B TradeCenter provides registration and agency services in the US and compliance for pharmaceutical companies. See on the side what our services include:

Owners or operators of all pharmaceutical establishments involved in the manufacture, preparation, propagation, composition or processing of medications must register and submit a list of all products that are commercially distributed in the United States. Companies outside the US. They must designate a US-based agent. The B2B TradeCenter provides registration services, agency services and compliance assistance.

The FDA requires that drug labels be indexed using the Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. The B2B TradeCenter adapts its drug labeling to comply with FDA regulations.

D-U-N-S® numbers are necessary for pharmaceutical establishments to register and list products with the FDA. The B2B TradeCenter can verify that your company has a D-U-N-S® and help you with registration to obtain a D-U-N-S®.


Medical Equipments

The FDA regulates all medical equipment intended for use in the diagnosis, cure, mitigation, treatment or prevention of diseases that affect the structure or any function of the body of humans or animals that is commercially distributed in the United States. Foreign companies must designate an agent based in the United States. The B2B TradeCenter provides registration services, agency services and compliance assistance. See on the side what our services include:

Owners or operators of business units involved in the production and distribution of medical devices intended for commercial use in the United States require an annual registration with the FDA and, in many cases, it is also necessary to list their equipment. Companies involved in the manufacture, packaging, labeling or reprocessing of medical equipment must pay an annual fee. The B2B TradeCenter provides the registration of your company and the listing of your medical equipment.

With certain exceptions, most medical devices require FDA authorization before they can be marketed in the US. Notifying the FDA of its intention through a market notice (PMN) or 510 (k). According to 510 (k), a manufacturer must demonstrate that the device is "substantially equivalent" (as safe and effective) to an existing device in the market. If the FDA determines that the device is "substantially equivalent," the manufacturer may market it. The B2B TradeCenter can complete the 510 (k) application process for your medical equipment.

B2B TradeCenter provides the adaptation of medical device labeling to comply with FDA regulations.


Cosmetics

The FDA regulates cosmetic products intended for use in the United States, and the State of California imposes additional requirements for cosmetic products intended for use there. The B2B TradeCenter provides registration services, agency services and compliance assistance to companies in the cosmetic industry. See on the side what our services include:

We translate, review and adapt cosmetic labels to comply with FDA regulations. Our report identifies relevant standards, compliance guides, warning letters, import alerts and other guidance documents.

Certain cosmetic companies that wish to sell in the state of California, US must inform the ingredients of their products that can cause cancer, birth defects or other reproductive damage. The B2B TradeCenter helps companies determine which ingredients may be subject to this requirement and reports them to the authorities of the state of California.

The B2B TradeCenter helps companies with the reports required by California and the FDA, as well as with the registration of cosmetic establishments through the FDA's Voluntary Cosmetic Registration Program (VCRP).


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Contact us and request your fda

 201 S. Biscayne Blvd, Suite #1200
Miami, Florida - United States
[email protected]
+1-877-917-6650 / +55 11 99276-5429

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