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 have been providing regulatory consulting and registration services since 2009.
**Expertise & scope**
* FDA Drug Establishment Registration and Listing: Assists both domestic and foreign establishments in registering with the FDA and listing their commercially marketed drug products. This includes electronic submission requirements mandated by the Food and Drug Administration Amendments Act of 2007.
* US FDA Agent Services: Acts as a mandatory U.S. agent for foreign food, drug, and medical device establishments importing products into the United States. Responsibilities include serving as a communications link for routine and emergency FDA communications.
* NDC Number and Labeler Code Assignment: Guides clients through the process of obtaining an NDC Labeler code, which is a unique identifier for establishments or labelers, and understanding the structure of the National Drug Code (NDC) number.
* FDA Drug Label Review: Provides expert review of drug labels to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), identifying and correcting compliance gaps.
* FDA Drug Listing Renewal: Supports establishments in fulfilling annual drug listing update requirements, including submitting blanket no-change certifications.
* FDA Drug Reporting: Assists with the new requirement to report the amount of each listed drug manufactured for commercial distribution to improve FDA's visibility into drug supply chains.
* Certificate to Pharmaceutical Product (CPP): Facilitates the application process for obtaining a CPP, an internationally recognized document confirming a pharmaceutical product's marketing status and regulatory compliance for export.
**Reputation / proof points**
* Founded in 2009, offering regulatory consulting and registration services.
Liberty Management Group (FDA Registration & US Agent) is a consulting firm headquartered in Illinois, USA, specializing in FDA, CE Marking, and ISO compliance. They have been providing regulatory consulting and registration services since 2009.
**Expertise & scope**
* FDA Drug Establishment Registration and Listing: Assists both domestic and foreign establishments in registering with the FDA and listing their commercially marketed drug products. This includes electronic submission requirements mandated by the Food and Drug Administration Amendments Act of 2007.
* US FDA Agent Services: Acts as a mandatory U.S. agent for foreign food, drug, and medical device establishments importing products into the United States. Responsibilities include serving as a communications link for routine and emergency FDA communications.
* NDC Number and Labeler Code Assignment: Guides clients through the process of obtaining an NDC Labeler code, which is a unique identifier for establishments or labelers, and understanding the structure of the National Drug Code (NDC) number.
* FDA Drug Label Review: Provides expert review of drug labels to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), identifying and correcting compliance gaps.
* FDA Drug Listing Renewal: Supports establishments in fulfilling annual drug listing update requirements, including submitting blanket no-change certifications.
* FDA Drug Reporting: Assists with the new requirement to report the amount of each listed drug manufactured for commercial distribution to improve FDA's visibility into drug supply chains.
* Certificate to Pharmaceutical Product (CPP): Facilitates the application process for obtaining a CPP, an internationally recognized document confirming a pharmaceutical product's marketing status and regulatory compliance for export.
**Reputation / proof points**
* Founded in 2009, offering regulatory consulting and registration services.
Additional information
Liberty Management Group provides comprehensive support for foreign establishments needing to comply with U.S. FDA regulations. Their services are crucial for market access, ensuring products meet U.S. standards. They emphasize the importance of accurate drug listing and timely renewals to avoid products being deemed inactive and removed from the NDC directory. For medical device establishments, they assist in identifying a U.S. FDA agent, which is a mandatory part of the establishment registration process. The firm also guides clients through the complexities of drug label review, ensuring adherence to the FD&C Act for patient safety and to prevent enforcement actions. Their expertise extends to facilitating the export of U.S.-regulated products by assisting with the Certificate of Pharmaceutical Product (CPP) application.
Key Highlights
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Specializes in FDA Drug Establishment Registration and Listing for domestic and foreign entities.
Source
“Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States must register with the FDA.”
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Provides mandatory US FDA Agent services for foreign food, drug, and medical device facilities.
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 in obtaining NDC Numbers and Labeler Codes, crucial for drug identification.
Source
“The labeler code is a 5 digit number assigned by the FDA, this is a unique number for each labeler.”
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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 Certificate to Pharmaceutical Product (CPP) for exporting 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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Provides regulatory consulting and registration services since 2009.
Source
“Reliable FDA Consulting & Registration Since 2009”
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Headquartered in Illinois, USA, serving a global clientele.
Source
“Liberty Management Group Ltd is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Illinois, USA.”
Buyer Snapshot
Best for
- Foreign establishments needing FDA registration and a US Agent
- Drug manufacturers requiring NDC labeler codes and listing support
- Companies seeking assistance with FDA drug label compliance
How engagement typically works
- Consultative support for regulatory processes
- Guidance on FDA submission requirements
- Assistance with documentation and renewals
Typical deliverables
- FDA Establishment Registration
- US FDA Agent representation
- NDC Labeler Code assignment
- Drug Listing submissions
- Drug Label Review reports
- Certificate of Pharmaceutical Product (CPP)
Good to know
- Best when requiring specialized FDA regulatory expertise for drugs and medical devices.
- Ideal for foreign entities navigating U.S. market entry requirements.
Pricing
Model:
Retainer
Public range:
Publicly listed: USD 399 - USD 649
Notes:
Based on publicly listed information for specific services; 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 specific forms and information for registration and listing processes. For NDC Labeler Code, an 'NDC Labeler code request SPL' must be submitted electronically via ESG or CDER Direct Portal.
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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