Quick. Easy. Accurate.
FDA Registration & Compliance
Start selling in The United States With Complete Regulatory Support From Industry Experts
Beyond offering services, we complement your journey with our commitment to Satisfaction
Launch your products in the U.S. Market
Entering the U.S. market often requires FDA compliance with federal regulations. For companies engaged in selling food (food supplements, nutraceuticals), cosmetics, medical devices, and pharmaceutical products, facility registration and product listing are essential steps before products can be distributed or sold. Each category is governed by its own set of regulatory frameworks, documentation standards, and timelines that must be carefully followed to maintain FDA compliance.
At Mercurius, we assist clients to ensure their registration process is accurate, efficient, and aligned with U.S. FDA compliance requirements. Our services include DUNS number validation, FEI and NDC code acquisition, U.S. Agent appointment, and complete handling of all registration submissions. We support both first-time applicants and renewing facilities with a focus on FDA compliance, clarity, and speed.
Start in 3 Easy Steps
Register
We register your facility with the FDA. This includes DUNS number verification, FEI or NDC setup, and appointing a U.S. Agent for foreign companies
List
Each product is listed according to FDA regulations for your category, whether it is cosmetic, drug, or medical device.
Export
Once your facility is registered and your products are listed, you are FDA compliant and ready to export to the United States with all documentation in place.
Industries We Cater
To sell or distribute food products in the United States, registration with the U.S. FDA is mandatory for all facilities involved in:
1. Domestic and Foreign Facilities selling Food in the United States.
2. Human and Pet Food or Food Supplements or Nutraceuticals Facilities.
3. Manufactures, Packers, Re-packing, and Warehousing facilities.
Failure to register or renew on time can lead to shipment detentions, port refusals, and regulatory action.
Food facilities requiring additional procedures:
Acidified and canned foods
Organic food items
Alcoholic Beverages
Tobacco products
Arecanut products
Under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic facilities manufacturing or processing products for the U.S. market must be registered with the FDA. This applies to both domestic and international manufacturers, packers, and holders.
Failure to register or list products as required may result in product holds, regulatory notices, or removal from the U.S. market.
Who should apply for FDA Cosmetic Facility Registration?
Domestic and Foreign Facilities Selling Cosmetics In the United States.
Manufacturers
Who should do the FDA Cosmetic Listing?
Domestic and Foreign Facilities Selling Cosmetics In the United States.
Manufacturers, Brand Owners, and Distributors
Facilities involved in manufacturing, repacking, relabeling, or distributing drugs intended for the U.S. market must be registered with the FDA under 21 CFR. This includes over-the-counter (OTC) drug manufacturers, whether domestic or international.
Failure to register, list drug products, or obtain an NDC Labeler Code may result in product refusal, import alerts, or enforcement action.
Who should apply for US FDA Drug Facility Registration?
Domestic and Foreign Facilities selling Drug in the United States.
All domestic and foreign establishments that manufacture, repack, relabel, or import medical devices into the U.S. are required to register with the FDA under 21 CFR. Device listing is also mandatory for each marketed product.
Failure to register or list properly can lead to import delays, warning letters, and loss of market access.
Who should apply for US FDA Medical Device Establishment Registration?
Domestic and Foreign Medical Device Manufactures.
Initial Importer based in USA.
Initial Exporter from a foreign country. (The same firm can be the manufacturer also)
What We Can Do For You
A Streamlined, End-To-End Process To Get You U.S.-Market Ready
Eligibility Clarification
Understand whether your facility requires FDA registration and what compliance steps apply to your product type
DUNS Number Assistance
Receive expert support in obtaining or verifying your DUNS number, required for facility registration
U.S. Agent Representation
Gain access to a compliant, qualified U.S.-based agent to meet FDA foreign facility requirements
Facility Registration
Ensure your facility is properly registered under FDA guidelines, with full documentation handled for you
Renewal and Update Support
Stay compliant with timely help on biennial renewals, address changes, or ownership modifications
Final Registration Confirmation
Receive official documentation confirming FDA registration, allowing you to begin exports to the U.S
Seeking custom services?
Drop your email, and we’ll get in touch, or contact us directly.
Client Testimonials
Great work – love the dedicated member of the team that is assigned to work on my account.
Manvi and the team at Mercurius are excellent. We have been working with them for a number of years and they have been pivotal in keeping our accounts in good order.
Siddhartha is delightful to work with and always completes assignments ahead of schedule and with no iteration needed.
Pleasant to work with, knowledgeable on accounting principles, responsive
Sid and his team so excellent work – on time and very attentive to detail.
Why Mercurius?
200+ Ratings on Google
Experience the services that’s earned us top ratings.
Quick Registration Turnaround
Receive your FDA facility registration in as little as 3 business days, with full document handling from our team
Expert Compliance Support
Work with a dedicated team experienced in FDA regulations, timelines, and industry-specific requirements
Certified U.S. Agent Included
We provide a qualified U.S.-based agent to meet FDA requirements for foreign facilities at no extra cost
End-to-End Export Assistance
From initial assessment to final approval, we support your journey to become fully export-ready for the U.S. market
FAQs
What is the Eligibility for an FEI Number?
Facilities involved in manufacturing, processing, packaging, or storing FDA-regulated products must maintain FDA compliance and are eligible for an FEI number, typically assigned once the FDA initiates regulatory tracking or inspection.
What is the FEI Number Application?
It’s a request submitted to the FDA by a registered facility to obtain a unique FEI number for inspection, FDA compliance, or fee-related purposes.
What is the Role of an Agent in FDA Drug Establishment Registration & Listing?
A U.S. Agent acts as a liaison between the FDA and a foreign drug establishment, assisting with registration, communication, FDA compliance, and regulatory updates.
Who is Required to Self-Identify?
Facilities involved in manufacturing, testing, or packaging human generic drugs must self-identify with the FDA under GDUFA requirements to maintain FDA compliance.
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