Simplifying
FDA Compliance
for Global Innovation.
LMG provides expert guidance for Food, Drug, Medical Device, and Cosmetic regulations. Fast, transparent pricing, and trusted worldwide.
Certificate
FDA Regulatory Expertise — Food, Drug, Device & Cosmetics
Liberty Management Group Ltd is a globally recognized FDA consulting firm specializing in navigating the complex regulatory landscape for the food, drug, medical device, and cosmetic industries. We provide a comprehensive suite of end-to-end consulting services designed to help domestic and foreign establishments maintain seamless market access while ensuring total compliance with evolving U.S. federal standards. From initial facility registration and U.S. Agent representation to intricate technical filings, our team delivers the strategic oversight necessary to safeguard your global supply chain and accelerate innovation.
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FDA Drug Registration, Listing & Compliance
Registration, US Agent, NDC Number, Label Review, Listing, Drug Reporting, CPP, DMF, Self-Identification, Compounding Pharmacy Registration, OTC Drug Compliance, Drug Master File Amendments.
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FDA Medical Device Registration & 510(k)
Establishment Registration, US FDA Agent, Label Review, Device Listing, CFG, CFG-NE, 510(K), UDI Submission, Premarket Notification, Quality System Compliance, Import/Export Certification.
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FDA MoCRA Cosmetic Facility Registration
MoCRA Registration, Product Listings, Labeling Reviews, Export Certificates, US FDA Agent Service, Ingredient Safety Compliance, Adverse Event Reporting, Facility Renewal Management.
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FDA Food Facility Registration & FSMA
Registration, US Agent, FCE & SID, Prior Notice, Acidified Food filings, Certificate of Free Sale, Biennial Renewal, Dietary Supplement Compliance, Food Label Review, Animal Food Facility Registration.
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FDA Registration & Compliance Services
Expert regulatory support at every stage — from initial registration to ongoing compliance management.
The Foundational Step for U.S. Market Entry
FDA registration is mandatory for domestic and foreign establishments marketing food, drugs, medical devices, or cosmetics in the USA. Our experts identify the correct registration type for your facility and product category, ensuring your FEI number or facility registration number is issued accurately and without delay.
DetailsMandatory Representation for Foreign Establishments
Every foreign establishment must designate a U.S. FDA Agent as a local point of contact. Without a verified Agent, your registration cannot be completed or maintained. LMG provides professional 24/7 representation and direct liaison services between your firm and the FDA, fully satisfying this federal requirement.
DetailsEnsuring Uninterrupted Regulatory Compliance
Lapsed registrations can result in costly shipment holds. We manage biennial renewal for Food and Cosmetic Facilities (MoCRA) and annual renewal for Drug and Medical Device establishments. Our team ensures MDUFA user fees are paid on time and your listings remain continuously active each fiscal year.
DetailsUnderstanding What the FDA Actually Requires
Many businesses believe they need "FDA approval" to sell in the United States — but in most cases, what is actually required is FDA registration. FDA approval applies only to specific categories such as new drugs and certain medical devices. For food, cosmetic, supplement, and medical device companies, the FDA requires facility registration, product listing, and regulatory compliance.
DetailsFDA Certificates for Global Market Access
LMG issues a verifiable FDA registration certificate accepted by importers, customs brokers, and business partners worldwide as proof of your current registration status. We also assist with official FDA export certificates — the Certificate to Foreign Government (CFG) for medical devices, Certificate of Pharmaceutical Product (CPP) for drugs, and Certificate of Free Sale for food and cosmetic products.
DetailsYour FDA Facility Identifier for U.S. Compliance
An FDA FEI Number is a unique identifier assigned by the FDA to every registered facility that manufactures, processes, packs, or stores products for the U.S. market. It is required for food, drug, cosmetic, and medical device facilities and is directly linked to your FDA registration record. U.S. Customs uses your FDA FEI Number or DUNS Number to verify compliance when your products enter the country.
DetailsSpecialized FDA Regulatory Services — Including MoCRA Registration
Targeted regulatory expertise for specific compliance requirements — from MoCRA cosmetic registration and 510(k) submissions to SPL drug filings, DMF/eCTD preparation, food safety, drug amount reporting, and label compliance.
Mandatory Annual Reporting — Noncompliance Results in Public FDA Listing
The CARES Act requires all establishments registered under section 510 of the FD&C Act to report annually the quantity of each listed drug released into commercial distribution. Reports are due before March 31 each year. Registrants who miss the deadline may be publicly listed on FDA.gov as noncompliant — a reputational and regulatory risk that LMG helps you avoid through timely, accurate submission of your annual drug amount report.
Details →510(k) Clearance — From Predicate Selection Through FDA Review
Most Class II medical devices require a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device before entering the US market — no separate approval needed. LMG assists with the complete 510(k) process — predicate identification, technical documentation, test requirement planning, submission preparation, and responding to FDA deficiency letters — reducing review time and the risk of a Not Substantially Equivalent (NSE) determination.
Details →Effortless Label Compliance — Simpler, Faster, and Cost-Effective
Our experts review your label, identify compliance gaps, and deliver a revised, ready-to-use FDA-compliant version accurately and efficiently. We check ingredient status, marketing claims, and overall FDA compliance across food, drug, medical device, and cosmetic labels. Non-compliant labels can trigger warning letters, product detention, recalls, or import alerts — all of which our expert review helps you prevent before your product reaches the US market.
Details →US Importers Are Legally Responsible for Their Foreign Suppliers
The Foreign Supplier Verification Program (FSVP) requires US food importers to verify that foreign suppliers meet FDA food safety standards — responsibility rests with the importer, not the supplier. LMG develops complete FSVP programs, including written procedures, hazard analysis, supplier evaluation, verification activities, and FDA-inspection-ready documentation. LMG clients also benefit from LMG FDARegWatch — our complimentary service that monitors your FDA food facility registration status and alerts you before a lapsed registration disrupts your shipments.
Details →Structured Product Labeling for Human & Animal Drug Submissions
FDA requires drug establishment registrations, drug listings, and NDC requests to be submitted in Structured Product Labeling (SPL) format - a technically demanding XML standard. LMG uses its own proprietary software LMG SPLmatrix™ to prepare and submit SPL files with greater precision, consistency, and control. We handle human and animal drug establishment registrations, OTC drug listings with Drug Facts labeling, NDC labeler code assignments, and homeopathic drug establishment registrations and listings — ensuring accurate, error-free electronic submissions to the ESG NextGen system.
Details →Drug Master File Submission & eCTD Preparation - Supporting IND, NDA & ANDA Submissions
A Drug Master File (DMF) lets manufacturers submit confidential information about facilities, processes, or materials used in drug manufacturing directly to FDA — without disclosing it to the referencing applicant. LMG uses its own proprietary software LMG eCTD Pro™ to convert documents into eCTD format for DMF, IND, NDA, and ANDA submissions. We handle DMF submissions, eCTD conversions, and US FDA Agent services for foreign establishments — ensuring accurate, fully compliant electronic submissions to the ESG NextGen system.
Details →Proven Clearances
The following 510(K) Numbers represent successful submissions managed by LMG, verifiable via the FDA CDRH database.
Trusted Worldwide
Direct feedback from our medical device and food facility partners across the globe.
"LMG provided exceptional guidance for our 510(k) submission. Their knowledge of FDA technical requirements is second to none."
— Medical Device Manufacturer, South Korea
"The Compliance Monitor tool gives us peace of mind knowing our shipments are being watched daily. It's like having a dedicated FDA compliance team working around the clock for us."
— Food Export Operations Manager, India
Ready to Get Started?
Register Your Facility with LMG Today
Fast, transparent, and trusted by manufacturers in 150+ countries. Most registrations completed within 1–2 business days.
FDA Registration Fees — Price-Lock Stability Since 2009.
LMG has not increased its service fees since 2009. We offer highly competitive fixed rates for FDA registration, U.S. Agent representation, and NDC labeler code requests. No surprises — just predictable, affordable regulatory support.
LMG Compliance Monitorâ„¢
Real-Time Import Surveillance.
Complimentary for LMG clients. We protect your supply chain from unexpected disruptions by scanning official FDA databases every 24 hours. Our system identifies detentions or Import Red List changes affecting your firm in real-time, allowing you to address issues immediately and avoid significant port storage fees or shipment delays.
Frequently Asked Questions
Common questions about FDA registration, US Agent requirements, fees, timelines and compliance.
What is FDA registration?
FDA registration is required for facilities that manufacture, process, pack, or store products for the US market.
How long does the registration take?
Most registrations are completed within 1–5 business days depending on the type.
How much does the registration cost?
Costs vary based on the type of registration. You can contact for detailed pricing.
What happens if my registration lapses?
If your registration lapses, your facility becomes inactive and your products may be refused entry into the US. Immediate action is recommended.
Do I need 510(k) clearance?
Most Class II medical devices require 510(k) clearance before they can be marketed in the US.
What is the LMG Compliance Monitorâ„¢?
The LMG Compliance Monitorâ„¢ is a complimentary real-time surveillance service for LMG clients. It scans official import alert databases every 24 hours to identify detentions or import alert issues affecting your firm, alerting you immediately so you can act before shipments are held at port. The Compliance Monitor is included at no extra cost for clients who use LMG as their US Agent.
What is LMG eCTD Proâ„¢?
LMG eCTD Proâ„¢ is proprietary software developed and used exclusively by LMG to prepare pharmaceutical submissions for our clients. The tool enables our team to efficiently convert client documents into FDA-compliant eCTD format while maintaining accuracy and regulatory standards. This internal technology allows us to deliver faster turnaround times and higher quality control compared to manual conversion methods.
What is MoCRA registration and is it required?
MoCRA (Modernization of Cosmetics Regulation Act of 2022) requires all cosmetic manufacturers and processors to register their facilities and list their products with the FDA. It is mandatory for both domestic and foreign companies selling in the US.
Is a US Agent required for foreign establishments?
Yes, foreign establishments must appoint a US Agent to receive FDA communications.
Does LMG handle registration for all product categories?
Yes, LMG handles registration for food, drugs, medical devices, and cosmetics, along with related compliance services.
Does LMG provide a certificate after completing registration?
Yes, LMG provides a registration certificate as proof of compliance. The FDA itself does not issue certificates.
Does LMG provide label review services?
Yes, LMG offers label review services to ensure products meet regulatory requirements before entering the market.
Are all tools in the LMG Compliance Portal free to use?
Yes. All compliance tools in the LMG Compliance Portal are completely free to use at fdahelp.us — no registration, no subscription, and no sign-in required. The tools include the FDA Fee Estimator, Cosmetic Drug Classifier, MoCRA Product Code Builder, Food Facility Registration Navigator, Medical Device Classification Finder, NDC Validator, Drug Label Scanner, and more. Available exclusively on fdahelp.us.
What is LMG SPLmatrixâ„¢?
LMG SPLmatrixâ„¢ is proprietary software created and operated by LMG to process drug establishment registrations and listings on behalf of our clients. The platform allows our regulatory specialists to generate error-free SPL files and validate submissions before they reach FDA. By using this internal tool, we provide clients with a more reliable and efficient registration process than traditional manual preparation methods.
Still Have Questions?
Our Regulatory Specialists Are Ready to Help
We respond to all inquiries within one business day. No sales pressure — just expert guidance.