FDA Compliance Solutions for Drugs
The B2B TradeCenter provides full FDA compliance support for companies in the pharmaceutical industry that want to sell drugs — including OTC products — in the U.S. market. With a team of experienced regulatory specialists and former FDA staff, we ensure your product meets agency requirements with complete safety and efficiency.
FDA Registration
U.S. Agent Services
Product Review
Product Compliance
FDA Registration made Simple
FDA drug establishment registration can be a complex process, but we make it simple and stress-free. Our team of specialists will guide you through each step to ensure your establishment is properly registered with the FDA.
Here’s how our process works:
1
Fill out our comprehensive intake form abrangente. Submit your company details and our team will assist you in completing the form and gathering the necessary documentation.
2
Obtain your FDA registration. We handle submission of all required information and documents to the FDA, addressing any potential issues along the way.
3
Receive the certificate and official proof of registration. We provide clear and organized documentation for your records.
Get registered now!U.S. Agent Services for FDA Communication
If your company is located outside the U.S., you must appoint a U.S.-based agent. We serve as your reliable point of contact with the FDA.
Speak with a U.S. Agent!
Accurate reports on your facility’s identifiers (UFI, FEI)
Timely updates to your FDA registration
Forwarding and assistance with FDA communications
Drug Product Listing
Avoid problems with unlisted or improperly listed products. We list your products according to FDA and SPL (Structured Product Labeling) requirements.
Input of detailed information for each product (SKU)
Submission in FDA-validated SPL format
English translation with suggested improvements
Updates and listing reviews at least once per year
Review of Drug Labels
Avoid regulatory issues due to noncompliant drug labels. Our expert team conducts a full technical review of your labels to ensure they meet all FDA requirements.
Our service includes:
Detailed review of layout and content
Analysis of ingredients per FDA regulations
Technical report with required corrections and recommendations
Drug Ingredient Review
Our specialists analyze all components of your formula — including active ingredients, excipients, and additives — to ensure compliance with FDA standards.
Compliance verification for each ingredient
Review of substances based on regulatory thresholds
Correction of ingredient names and official coding
Still have questions about our services?
Read the most common questions
from
B2B TradeCenter
clients
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What is the FDA?
The FDA (Food & Drug Administration) is the U.S. federal agency responsible for regulating drugs, food, cosmetics, and other products to ensure the safety and effectiveness of products marketed in the country.
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What is FDA Registration?
FDA registration is required for all facilities that manufacture, pack, or distribute drugs in the U.S. It allows the FDA to monitor operations and enforce safety standards.
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Do I need a U.S. Agent?
Foreign drug facilities must designate a U.S. Agent to handle FDA communications and provide support in case of emergencies or inspections.
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How does drug approval work in the U.S.?
Depending on the product, drugs may require premarket approval via a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). OTC drugs may be marketed under an FDA monograph or require listing and labeling compliance.
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Do you help with labeling?
Yes. We provide label reviews and corrections to ensure compliance with all FDA formatting, content, and submission requirements.
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How do I know if my ingredients are allowed in the U.S.?
We verify each component of your formula, including active and inactive ingredients, against FDA regulations, approved substance lists, and concentration limits.
