B2B TradeCenter is part of B2USA, the largest network of online B2B marketplaces in the Americas, with hundreds of thousands of registered companies. We have offices and affiliations in Brazil, USA, Colombia and China.
One of the Foreign Trade services we provide is compliance and registration of companies and products and companies with regulatory agencies in the USA (the FDA) and Brazil (ANVISA) for the following sectors:
We Have a Trade Team
Specialized In International Business
Why B2B Tradecenter?
|Competition, Competitors or Other
|Offers complete solutions
for Foreign Trade
Yes, as part of the largest network of B2B
portals in the Americas
|Offices in the Americas||Most do not||
Yes, in the USA and Brazil
em SÃo Paulo
|Flexible Payment Terms||Only US Dollar||Accept Local Currencies|
|Price||High Cost / Variable and Fixed||Low Cost / Fixed|
|Payment Terms||Credit Card Credit Card||Payable in Installments by multiple methods Payable in Installments by multiple methods|
|Tax Invoices||Most do not||Yes|
Our team includes US-based FDA and Brazil-based ANVISA experts, attorneys and consultants. We also help companies comply with USDA (food) and TTB (alcoholic beverage) requirements. B2B TradeCenter is not affiliated with the US FDA, USDA and TTB, nor with Brazilâ€™s ANVISA or MAPA. Our services are always provided at competitive fees, with the possibility of payments in installments.
B2B TradeCenter is your trusted partner unlike any other option Food, Drug and Cosmetics compliance services. The services described below focus on the USA and FDA, but we also provide the services for Brazil and ANVISA.p>
Foods and Beverages
The FDA regulates foods, beverages and dietary supplements intended for human or animal consumption within the USA. B2B TradeCenter provides US Registration, Agency and regulatory compliance assistance to US and foreign companies in the food, beverage and dietary supplement industries.
Also, the B2B TradeCenter helps companies comply with USDA (food) and TTB (alcoholic beverages) requirements.
US FDA Registration and US Agent Requirements:
FDA registration is required for all facilities that manufacture, process, package, or store foods, beverages, or dietary supplements that may be consumed in the United States by humans and/or animals. Foreign companies must designate a US-based agent for communications with the FDA.
We offer product composition ingredient research service. The review will ensure that the ingredients are generally recognized as safe (GRAS), if they are free to use, or if there is some level of restriction, and we will recommend a course of action, including petitioning the FDA.
Food, Beverage, Supplement and Ingredient Label Review:
We translate, review and adapt food, beverage or dietary supplement labels to comply with FDA regulations. Our report may identify relevant standards, compliance guides, warning letters, import alerts and other guidance documents
Registration of Establishments and Drug Listings with the FDA:
Owners or operators of all facilities involved in the manufacture, preparation, propagation, compounding or processing of drugs must register their establishments and submit a list of all products in commercial distribution in the United States. Foreign companies must designate a US-based agent. B2B TradeCenter provides US registration, agency and compliance assistance.
Drug and Ingredient Labeling Reviews:
The FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. B2B TradeCenter makes every adaptation of its drug labeling to comply with FDA regulations.
Universal Data Numbering System (DUNSÂ®):
DUNSÂ® numbers are required for drug establishments to register and list products with the FDA. B2B TradeCenter can verify that your company has a DUNSÂ® and assist in registering to obtain a DUNSÂ®. (DUNSÂ® is a trademark of The Dun and Bradstreet Corporation.)
The FDA regulates drugs intended for use in diagnosing, curing, mitigating, treating, or preventing disease and that affect the structure or any function of the body of humans or animals. B2B TradeCenter provides US registration, agency, and compliance for pharmaceutical companies.
The FDA regulates all medical equipment intended for use in diagnosing, curing, mitigating, treating, or preventing diseases that affect the structure or any function of the human or animal body that is in commercial distribution in the United States. Foreign companies must designate a US-based agent. B2B TradeCenter provides US registration, agency and compliance assistance.
Registration of Establishments and Listings of Medical Equipment with the FDA:
Companies involved in the manufacture, packaging, labeling, or reprocessing of medical devices intended for commercial use in the United States are required to register their establishment, designate a responsible US agent, and arrange for the listing of their products at the FDA. B2B TradeCenter arranges proper registration of your company, listings of your medical equipment and we act as your agent in the USA.
Pre-Market Notice (PMA) or Form 510(k)
Manufacturers wishing to introduce class 2 medical devices into the US (and in certain cases, class 1 and 3 devices), must submit their form 510(k) to the FDA. Under 510(k), a manufacturer must demonstrate that the device is "substantially equivalent" to a device already on the market, meaning it is as safe and as effective. If the FDA determines that the device is "substantially equivalent," the manufacturer may market it. The 510(k) is also required when the manufacturer changes the product's intended use, or when a product already released for sale has its technology changed in a way that impacts safety or effectiveness. B2B TradeCenter supports you throughout the entire process of applying 510(k) to your medical equipment.
Medical Device Labeling and Product Reviews
B2B TradeCenter provides adaptation of medical device labeling to comply with FDA regulations.
Cosmetic Label Review and Adaptation:
We translate, review and adapt cosmetic labels to comply with FDA regulations. Our report may identify relevant standards, compliance guides, warning letters, import alerts and other guidance documents.
We offer product composition ingredient research service. The review will ensure that the ingredients are generally recognized as safe (GRAS), are free to use, and if there is some level of restriction, we will recommend a course of action, including petitioning the FDA.
California Safe Cosmetics Act (CSCA):
The State of California has a separate legislation for cosmetics, where it is necessary to review a productâ€™s ingredients against a published list of substances to determine if it is prohibited from commercialization or requires safety warnings. If your company is not sure about possible restrictions on ingredients composing the product, then you should consider this review in accordance with the CSCA.
Voluntary Cosmetic Registration Program:
For the cosmetics category, there is no requirement to register establishments or to list products, however there is a voluntary registration program (VCRP), which some companies choose to do as a matter of commercial strategy or request of their customers. The B2BTradeCenter fully supports FDA cosmetics compliance procedures.
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 in that state. The B2B TradeCenter provides US registration, agency and compliance assistance services to companies in the cosmetics industry.
We are proud to be part of amazon's international network of service providers for entrepreneurs
We are part of a select group of companies recommended by Amazon to help companies that want to sell through their marketplace.
Through Amazon SPN, we help companies that need FDA Registration, label review, ingredients review, FSMA (supplier to USA) plan and FSVP (importer in USA) plan and agency.Talk to one of our specialists