FDA Drug Registration &
Compliance Services
Expert guidance for domestic and foreign drug establishment registration, NDC labeler code assignments, drug listings, and annual reporting. LMG ensures your pharmaceutical products meet every FDA requirement.
Drug Establishment Registration Requirements
All domestic and foreign establishments that manufacture, prepare, propagate, compound, or process drug products intended for distribution in the United States must register with the FDA under Section 510 of the Federal Food, Drug, and Cosmetic Act. This applies to finished drug manufacturers, API manufacturers, repackers, relabelers, and contract manufacturers.
Registration must be completed before distributing drugs in the U.S. market, and must be renewed annually between October 1 and December 31. Failure to register or renew can result in your products being refused entry at U.S. ports and appearing on FDA’s import alert list.
Our Drug Regulatory Services
Complete FDA compliance solutions for pharmaceutical manufacturers, importers, and distributors worldwide.
Drug Establishment Registration
Initial registration for domestic and foreign drug manufacturers, repackers, relabelers, and contract manufacturers under 21 CFR Part 207.
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NDC Labeler Code Assignment
Obtain your National Drug Code (NDC) labeler code prefix from FDA — required before assigning NDC numbers to your drug products.
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Drug Listing
Submit structured product labeling (SPL) drug listings for all finished and bulk drug products to maintain active FDA registration status.
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Registration Renewal
Annual drug establishment registration renewal between October 1–December 31. Missing the deadline results in lapsed status and potential import holds.
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U.S. FDA Agent
Mandatory for all foreign drug establishments. LMG acts as your official U.S. Agent, serving as the direct point of contact between your firm and the FDA.
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Drug Amount Reporting
Annual CARES Act reporting of commercial drug distribution amounts. Must be submitted by March 31 to avoid public noncompliance listing on FDA.gov.
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Drug Label Review
Expert review of your drug product labels for FDA compliance — checking ingredient declarations, required statements, and marketing claims.
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Certificate of Pharmaceutical Product (CPP)
A Certificate of Pharmaceutical Product (CPP) is an FDA-issued document confirming that a drug product is legally marketed in the United States.
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Drug Master Files (DMF)
Preparation and submission of Drug Master Files to FDA for APIs, excipients, packaging materials, and manufacturing facilities.
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How the Registration Process Works
Our streamlined process gets your establishment registered quickly and accurately.
Initial Assessment
We review your facility details and product information to determine registration requirements. Our team identifies the appropriate registration category and gathers all necessary documentation.
SPL Preparation
Using LMG SPLmatrixâ„¢, we prepare your Structured Product Labeling (SPL) files with complete accuracy. All establishment and product data is converted into FDA-compliant XML format.
FDA Submission
We submit your SPL files directly to FDA's ESG NextGen system on your behalf. Our team monitors the submission process and addresses any validation issues immediately.
Verify on FDA Site
After submission, we verify that your registration information appears correctly on FDA's public database. You receive a confirmation email from us with the direct FDA link to your official registration.
Why Choose LMG
Trusted by businesses in 150+ countries for accurate, fast, and affordable FDA compliance.
Fast Turnaround
Most registrations completed within 1–3 business days. We understand that time-to-market matters.
Secure & Confidential
Your product formulations and business data are handled with strict confidentiality protocols.
150+ Countries Served
We have successfully registered establishments from over 150 countries in the FDA system.
Price-Lock Since 2009
LMG has never raised its fees. Transparent, fixed pricing with no hidden charges ever.
Dedicated Support
Direct access to your regulatory specialist throughout the entire registration process.
Verified Results
We issue registration certificates, which are industry-recognized and verifiable on our website.
Ready to Register Your Drugs with the FDA?
LMG has been helping businesses worldwide achieve and maintain FDA compliance since 2009. Our team is ready to guide you through every step of the process.