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, including electronic submissions.
* US FDA Agent Services: Acts as a mandatory US FDA Agent for foreign food facilities, medical device establishments, and drug establishments, serving as a communication link with the FDA.
* NDC Number and Labeler Code Assignment: Guides clients through the process of obtaining an NDC Labeler code by submitting an "NDC Labeler code request SPL" via the ESG or CDER Direct Portal.
* 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 gaps and offering revised, compliant versions.
* Drug Listing Renewal: Manages the annual drug listing update requirements, including blanket no-change certifications, to maintain product listings and avoid inactivation.
* FDA Drug Reporting: Assists with the new requirement to report the amount of each listed drug manufactured for commercial distribution.
* Certificate of 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**
* Established in 2009, indicating over a decade of experience in regulatory compliance.
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, including electronic submissions.
* US FDA Agent Services: Acts as a mandatory US FDA Agent for foreign food facilities, medical device establishments, and drug establishments, serving as a communication link with the FDA.
* NDC Number and Labeler Code Assignment: Guides clients through the process of obtaining an NDC Labeler code by submitting an "NDC Labeler code request SPL" via the ESG or CDER Direct Portal.
* 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 gaps and offering revised, compliant versions.
* Drug Listing Renewal: Manages the annual drug listing update requirements, including blanket no-change certifications, to maintain product listings and avoid inactivation.
* FDA Drug Reporting: Assists with the new requirement to report the amount of each listed drug manufactured for commercial distribution.
* Certificate of 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**
* Established in 2009, indicating over a decade of experience in regulatory compliance.
Additional information
Liberty Management Group emphasizes the critical nature of accurate and compliant labeling for patient safety, market access, and avoiding regulatory actions such as warning letters, import alerts, and recalls. They highlight that drug establishment registration and drug listing information must now be submitted electronically, unless a waiver is granted, following changes from the Food and Drug Administration Amendments Act of 2007. For foreign establishments importing drugs into the U.S., identifying a U.S. agent is a mandatory requirement, and this agent must be available to communicate with the FDA. The firm's services aim to streamline these complex processes for their clients.
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 comprehensive drug label review services to ensure compliance with the FD&C 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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Assists with obtaining an NDC Labeler code, a unique identifier for drug products.
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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Manages annual drug listing renewal requirements and blanket no-change certifications.
Source
“Drug listing update or blanket listing certification must submit every year during the renewal period, which is October 1st to December 31st.”
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Facilitates the issuance of Certificates to Pharmaceutical Product (CPP) for exporting U.S.-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 compliance.
Source
“Liberty Management Group Ltd is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Illinois, USA.”
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In operation since 2009, providing regulatory consulting and registration services.
Source
“Reliable FDA Consulting & Registration Since 2009”
Buyer Snapshot
Best for
- Foreign companies seeking FDA registration and US Agent services.
- Manufacturers requiring assistance with drug establishment registration and listing.
- Companies needing expert review of drug labels for compliance.
How engagement typically works
- Consultative approach to regulatory compliance.
- Assistance with electronic submissions and documentation.
Typical deliverables
- FDA Establishment Registration documentation.
- US FDA Agent representation.
- Compliant drug labels.
- Drug Listing renewal submissions.
- Certificate of Pharmaceutical Product (CPP).
Good to know
- Best when clients require specialized FDA regulatory support for drugs and medical devices.
- Engagements require clear communication regarding product details and regulatory history.
Pricing
Model:
Retainer
Public range:
Publicly listed: USD 399 - USD 649
Notes:
Pricing is based on publicly listed information for specific services and may vary.
“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
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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. Foreign establishments must identify a US FDA agent as part of the establishment registration process.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Drugs, Medical Devices
Registration Support
Yes, for drug establishments and medical device establishments.
US Entity State
Illinois
Recall Support
No
Inspection Support
No
Emergency Contact24x7
No, US FDA agent must be available during regular business hours.
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