Simplifying FDA registration and DUNS acquisition for businesses entering regulated U.S. markets.
Guided facility registration, product listing support, and compliance reminders.
Prepare a complete DUNS request and avoid preventable delays.
Not sure which FDA or DUNS filing applies? A specialist can help you identify the right path.
Clear, concise definitions to help you understand what each identifier means and why they matter for regulated U.S. business operations.
Food and Drug Administration
The FDA is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and related products. Businesses in regulated industries must register with the FDA to legally market and sell their products in the United States.
Data Universal Numbering System
A DUNS number is a unique 9-digit identifier assigned by Dun & Bradstreet. It is used to establish a business’s credibility and is often required for government contracts, FDA registration, and other regulatory filings tied to U.S. business identity and compliance.
Having both ensures your business meets federal regulatory requirements and can operate legally in regulated markets—supporting product compliance, government visibility, and long-term business credibility.
We guide your business through FDA filing and DUNS acquisition so you can enter regulated U.S. markets with confidence.
Share your company, facility, and product information. We review the details needed for FDA registration and DUNS eligibility.
Our team prepares your FDA submission and DUNS request, checks completeness, and coordinates the filing process for you.
Once approved, you receive your FDA registration confirmation and DUNS number, with clear next steps for U.S. market access.
Track renewal deadlines, update product listings, and keep your registration current with ongoing compliance support.
We support businesses entering regulated U.S. markets with FDA registration, product listing, DUNS acquisition, renewals, compliance guidance, and U.S. agent services.
Register manufacturing, processing, packing,...
Submit product codes and classification deta...
Prepare and submit a complete DUNS reques...
Stay current with renewal deadlines and upd...
Get expert guidance on registration scope, cl...
Maintain a U.S. address for FDA notices and...
FDA registrations require annual renewal. Missing the deadline means losing your ability to legally sell in the U.S.
We audit your current FDA registration details and product listings for accuracy.
We file your annual FDA renewal before the October–December deadline.
We confirm your registration is active and properly listed in FDA databases.
We track regulatory changes and notify you of any new requirements.
Your FDA registration becomes inactive, your products can be detained at the border, and you may face FDA enforcement action including import alerts and warning letters.
Choose the service your business needs for FDA registration, DUNS acquisition, or U.S. agent support.
FDA
A professionally prepared duns service with secure filing, clear guidance, and specialist support.
FDA
A professionally prepared fda registration service with secure filing, clear guidance, and specialist support.
FDA
A professionally prepared u.s. agent service with secure filing, clear guidance, and specialist support.
Clear answers about registration, DUNS acquisition, renewals, and U.S. market readiness.
FDA registration identifies your facility and products with the U.S. Food and Drug Administration. It is required for many businesses that manufacture, process, pack, or distribute regulated products in the United States.
A DUNS number is a unique business identifier used to establish your company’s identity and credibility. It may be required for FDA registration, government contracts, and other regulatory filings.
The timeline depends on your facility, products, and the completeness of the information provided. We review your details first and keep you informed throughout the filing process.
Yes. Many FDA registrations require annual renewal. We help track renewal windows, update product information, and keep your registration current.
Foreign businesses that market regulated products in the United States may need a U.S. agent for FDA communications. We can help you understand the requirement and provide ongoing support.
Simplify FDA compliance and DUNS acquisition with expert support for U.S. Agent services, annual compliance, and fast regulatory onboarding.
