We make
selling
to the
USA
easier
We are the solution your company needs to sell your products with regulatory compliance and FDA approval, in a simple, fast and secure way.
Part of the International
Network of Service Providers for
FDA compliance specialists with registration completed in up to 2 days
Technical and regulatory specialists, and former FDA employees
Offices in the USA and the Americas
Pay in your
local currency,
in
installments
Some of our Clients
Get to know the B2B TradeCenter
The B2B TradeCenter, part of B2USA, facilitates and supports international business transactions for small and medium-sized enterprises, with a focus on import and export. We provide expertise and a specialized team to assist companies in their internationalization through foreign trade.
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More than
1.000
Clients served
Service available in
4
languages
Chinese, Spanish,
English and Portuguese
Over
30
years of experience
Clients in more than
100
countries
Why choose B2B TradeCenter?
Our FDA services
Food and Beverages
We help ensure that your food and beverage products comply with FDA requirements, including registration, U.S. agent services, ingredient review, and label adaptation. We also provide the FSVP plan in compliance with FSMA law and handle the legalization of alcoholic beverages with the TTB.
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Dietary Supplements
We offer complete services for dietary supplements, including registration, U.S. agent services, ingredient review, label adaptation, and preparation of the FSVP plan for FDA compliance and commercialization in the U.S.
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Cosmetics
We support cosmetic companies in the FDA registration process and product listing as required by the new MoCRA law. We review ingredients and adapt labels to meet FDA regulations and California state law (CSCA / Prop 65), enabling access to the U.S. market.
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Drugs
We provide support to drug manufacturers in the FDA registration process, including product listing and label adaptation according to required regulations. We also assist with meeting the FDA’s required presentation format, such as Structured Product Labeling (SPL), and with regulatory analysis of ingredients and formulations.
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Medical Devices
We help medical device companies with the FDA registration process, including product listing and label adaptation for Class I and II devices. Additionally, for Class II devices, we provide guidance on submitting the 510(k) process in accordance with applicable regulatory requirements.
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B2B TradeCenter and
- Your Bridge to Selling in the U.S.
- Your Bridge to Selling in the U.S.
SPN
B2B TradeCenter is an official partner of Amazon through the Amazon Service Provider Network (SPN) – a global network of vetted service providers selected to assist businesses at every stage of their Amazon selling journey.
SELL ON AMAZON US
Every day, we help companies sell on Amazon in the United States, guiding sellers to understand and comply with U.S. regulatory requirements.
PARTICIPATION IN EVENTS
We take part in events and trade shows at Amazon's invitation, with the goal of training new sellers and providing guidance on the requirements to start operations in the U.S.
CONTACT WITH AMAZON
We can refer our regulatory services clients directly to the Amazon team, which then contacts them with personalized guidance and strategic support for participating in Global Selling.
Companies around the world trust us to ensure compliance and data security
Become one of our clientsYour Trusted Partner
Your trusted partner at the B2B TradeCenter, we combine industry knowledge with a personalized approach to help companies of all sizes achieve FDA compliance without unnecessary complications.
Speak with a Specialist
Still have questions about our services?
Read the most common questions
from
B2B TradeCenter
clients
-
What is the FDA?
The FDA (Food and Drug Administration) is the US federal agency responsible for regulating products such as food, beverages, dietary supplements, cosmetics, medical devices, and medications to ensure public health. To sell these products in the U.S., compliance with FDA regulations is required.
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What is FDA Registration?
FDA registration is mandatory for manufacturers, processors, and packers of products regulated by the FDA. It allows the FDA to identify and monitor facilities that produce goods for the U.S. market. We help ensure your registration process is done correctly and efficiently.
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Do I need an Agent in the U.S.?
The FDA requires all foreign facilities to designate a U.S. Agent, who will serve as the contact point for regulatory communications. If your facility is located outside of the US, we act as your official U.S. Agent, ensuring reliable representation and support.
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Do you help with labeling?
Yes. We offer complete label review and correction services, ensuring compliance with FDA labeling rules, including MoCRA requirements for cosmetics and California regulations (Prop 65). We handle all translation, formatting, claims, and ingredient listing.
-
How do I know if my ingredients
are allowed in the U.S.?Our ingredient review checks whether each ingredient complies with FDA regulations. We assess GRAS status, identify restricted or prohibited substances, and verify the need for California Prop 65 warnings. We provide all necessary documentation to ensure regulatory compliance.
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What if I'm just exploring the U.S. market?
We offer consulting services to provide a clear overview of FDA compliance requirements. These services are ideal for companies evaluating U.S. market opportunities before committing to full registration and market entry.
The services were delivered efficiently, fully meeting our practical and effective solutions for complying with all regulations.
Cacau Show
Much gratitude to B2B TradeCenter for the professionalism and support in obtaining FDA registration and compliance. An essential partnership to validate our purpose of bringing health, inclusion, and excellence to the world.
éDolce
B2B TradeCenter is highly responsive and provides excellent guidance throughout the entire process. They are with us at every stage, ensuring smooth and efficient progress.
Six Skins Health and Beauty
Excellent company, great service, great professionals, quick responses, clear communication—a serious company that knows what it’s doing.
Uniworld Solutions
We chose B2B TradeCenter for the ease of payment in Brazilian reais and support in Brazil. The team was quick, addressed our urgency, and delivered ahead of schedule. We recommend them for the great experience.
Cacaufoods
I used B2B TradeCenter’s services for FDA registration and was very well assisted throughout the process. Attentive and fast service.
L'USINE
I recommend the B2B TradeCenter for their personalized service, quick responses, and full support with the registration and U.S. agent services for our unit in the U.S. market.
Soft Arábica Armazéns Gerais
We recommend B2B for their professionalism, effectiveness, and transparency—always clarifying doubts and guiding us to securely structure our U.S. operations.
Natty Chews