Liberty Management Group (FDA Registration & US Agent)
Liberty Management Group Ltd
Liberty Management Group Ltd is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Illinois, USA. They specialize in FDA registration, US FDA agent services, and regulatory compliance for various product types.
Liberty Management Group Ltd (LMG) is a globally recognized consulting firm specializing in FDA regulations, CE Marking, and ISO standards. Headquartered in Aurora, Illinois, USA, LMG offers a comprehensive suite of services to both domestic and foreign establishments. Their expertise includes FDA registration for food, drugs, APIs, medical devices, and cosmetics, as well as acting as a US FDA Agent for foreign establishments. LMG also provides services related to NDC Labeler Code requests, Drug Master Files, Drug Establishment Registration and Renewal, Premarket Notification (510k), Establishment Registration and Listing, Medical Device Labeling, and UDI submission. LMG is committed to helping clients navigate complex regulatory requirements, ensuring compliance with FDA mandates such as drug reporting, cosmetic facility registration and listing under MoCRA, and unique device identification (UDI) systems. They offer competitive fees and transparent pricing, assisting businesses in successfully bringing their products to the US market.
About
**Who they are**
Liberty Management Group (FDA Registration & US Agent) is a consulting firm headquartered in Illinois, USA, specializing in FDA, CE Marking, and ISO compliance. They offer regulatory support for various product types, including drugs, food, and medical devices.
**Expertise & scope**
* FDA Drug Establishment Registration and Listing: Assists domestic and foreign establishments in registering with the FDA and listing all commercially marketed drug products, including electronic submissions.
* US FDA Agent Services: Acts as a communications link between foreign establishments and the FDA for routine and emergency communications, a mandatory requirement for foreign food facilities and medical device establishments importing into the US.
* NDC Number and Labeler Code Assignment: Guides clients through the process of obtaining an NDC Labeler code, a unique identifier for establishments, and understanding NDC number structure.
* FDA Drug Label Review: Ensures drug labeling complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act), covering aspects like Drug Facts panel requirements, indications, and warnings.
* Drug Listing Renewal: Manages the annual drug listing update and blanket submission process, ensuring products remain active in the FDA directories.
* Drug Amount Reporting: Assists with reporting the quantity of each listed drug manufactured for commercial distribution, a requirement to identify and mitigate potential drug shortages.
* Certificate to Pharmaceutical Product (CPP): Facilitates the application process for CPPs, which confirm a pharmaceutical product's marketing status and regulatory compliance for export.
**Reputation / proof points**
* Consulting since 2009.
Liberty Management Group (FDA Registration & US Agent) is a consulting firm headquartered in Illinois, USA, specializing in FDA, CE Marking, and ISO compliance. They offer regulatory support for various product types, including drugs, food, and medical devices.
**Expertise & scope**
* FDA Drug Establishment Registration and Listing: Assists domestic and foreign establishments in registering with the FDA and listing all commercially marketed drug products, including electronic submissions.
* US FDA Agent Services: Acts as a communications link between foreign establishments and the FDA for routine and emergency communications, a mandatory requirement for foreign food facilities and medical device establishments importing into the US.
* NDC Number and Labeler Code Assignment: Guides clients through the process of obtaining an NDC Labeler code, a unique identifier for establishments, and understanding NDC number structure.
* FDA Drug Label Review: Ensures drug labeling complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act), covering aspects like Drug Facts panel requirements, indications, and warnings.
* Drug Listing Renewal: Manages the annual drug listing update and blanket submission process, ensuring products remain active in the FDA directories.
* Drug Amount Reporting: Assists with reporting the quantity of each listed drug manufactured for commercial distribution, a requirement to identify and mitigate potential drug shortages.
* Certificate to Pharmaceutical Product (CPP): Facilitates the application process for CPPs, which confirm a pharmaceutical product's marketing status and regulatory compliance for export.
**Reputation / proof points**
* Consulting since 2009.
Additional information
Liberty Management Group provides comprehensive support for foreign establishments needing to comply with US FDA regulations. Their US FDA Agent service is crucial for foreign food facilities and medical device manufacturers importing products into the United States. They emphasize that the US FDA agent must reside in or maintain a place of business in the USA and be available during regular business hours. The firm also guides clients through complex processes like drug establishment registration, drug listing, obtaining NDC numbers, and drug label reviews, ensuring products meet regulatory requirements before market entry. They also assist with obtaining Certificates of Pharmaceutical Product (CPP) for exporting FDA-regulated products.
Key Highlights
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Specializes in FDA drug establishment registration and US FDA agent services for foreign companies.
Source
“Foreign establishments that manufacture, repack, or re-label drug products and import or offer to import drug products to the United States must register with the FDA and identify a U.S. agent.”
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Provides US FDA Agent services, acting as a communications link for foreign food facilities and medical device establishments.
Source
“US FDA Agent is a mandatory requirement for foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S.”
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Assists with obtaining NDC Numbers and Labeler Codes, including the electronic submission of SPLs.
Source
“In order to get the NDC Labeler code, the labeler need to prepare and submit an "NDC Labeler code request SPL" to FDA.”
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Offers FDA Drug Label Review services to ensure compliance with the Federal Food, Drug, and Cosmetic Act.
Source
“FDA drug label review is a critical regulatory process that ensures drug labeling complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
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Facilitates the application for Certificates of Pharmaceutical Product (CPP) for exporting FDA-regulated products.
Source
“A Certificate of Pharmaceutical Product (CPP) is an internationally recognized document that confirms a pharmaceutical product's marketing status and regulatory compliance.”
Certifications & Trust Signals
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Consulting firm with expertise in FDA, CE Marking, and ISO.
Source
“Liberty Management Group Ltd is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Illinois, USA.”
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Operating since 2009, providing regulatory consulting and registration services.
Source
“Reliable FDA Consulting & Registration Since 2009”
Buyer Snapshot
Best for
- Foreign companies seeking US FDA registration and representation
- Manufacturers requiring US FDA agent services
- Companies needing assistance with drug listing and compliance
How engagement typically works
- Consultative support for regulatory processes
- Guidance on FDA requirements and submissions
- Acting as a designated US FDA Agent
Typical deliverables
- FDA Establishment Registration
- US FDA Agent representation
- Drug Listing and Renewal submissions
- NDC Labeler Code assignment
- Drug Label Review reports
- Certificate of Pharmaceutical Product (CPP)
Good to know
- Best when requiring a US-based entity to act as a regulatory liaison
Pricing
Model:
Retainer
Public range:
Publicly listed: USD 399 - USD 649
Notes:
Based on publicly listed information; final fees depend on scope.
“Pricing: USD 649; USD 399; USD 649”
HQ:
Aurora, USA
Languages:
English, Spanish
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Dietary supplements, Medical devices
Portfolio:
6-25
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 600
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Annual Renewal Support:
Yes
Registration Support:
Yes
Annual Renewal Reminder:
Yes
Product Type:
food, drugs, devices, cosmetics
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting
Emergency Contact24x7:
Yes
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Requires submission of an 'NDC Labeler code request SPL' via ESG or CDER Direct Portal for labeler code assignment. Drug establishment registration and listing information must be submitted electronically.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Drugs, Medical Devices, Food
Registration Support
Yes
US Entity State
Illinois
Recall Support
No
Inspection Support
No
Emergency Contact24x7
No
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