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 regulatory compliance.
**Expertise & scope**
* FDA registration and US FDA Agent services for various product types.
* Assistance with NDC Labeler Code requests, including SPL submissions via ESG or CDER Direct Portal.
* Support for Drug Establishment Registration and Drug Listing, including electronic submissions as required by FDAAA.
* Guidance on FDA Drug Reporting requirements for manufactured, prepared, compounded, or processed drugs.
* Services related to FDA Unique Device Identification (UDI) system implementation.
* Cosmetic Facility FDA Registration and Listing under the Modernization of Cosmetics Regulation Act (MoCRA), including biennial renewal.
* US FDA Food Facility Registration and compliance with FSMA requirements, including US FDA Agent services for foreign food facilities.
**Reputation / proof points**
* Globally recognized consulting firm.
* Serves clients in the US and internationally.
Liberty Management Group (FDA Registration & US Agent) is a consulting firm headquartered in Illinois, USA, specializing in FDA, CE Marking, and ISO regulatory compliance.
**Expertise & scope**
* FDA registration and US FDA Agent services for various product types.
* Assistance with NDC Labeler Code requests, including SPL submissions via ESG or CDER Direct Portal.
* Support for Drug Establishment Registration and Drug Listing, including electronic submissions as required by FDAAA.
* Guidance on FDA Drug Reporting requirements for manufactured, prepared, compounded, or processed drugs.
* Services related to FDA Unique Device Identification (UDI) system implementation.
* Cosmetic Facility FDA Registration and Listing under the Modernization of Cosmetics Regulation Act (MoCRA), including biennial renewal.
* US FDA Food Facility Registration and compliance with FSMA requirements, including US FDA Agent services for foreign food facilities.
**Reputation / proof points**
* Globally recognized consulting firm.
* Serves clients in the US and internationally.
Additional information
Liberty Management Group (FDA Registration & US Agent) provides specialized support for navigating complex FDA regulations across multiple product categories. For drug-related services, they assist with obtaining NDC Labeler Codes and fulfilling Drug Establishment Registration and Listing requirements, emphasizing electronic submissions. They also offer guidance on drug reporting obligations. For medical devices, their services extend to the FDA UDI system. Furthermore, they are equipped to handle Cosmetic Facility Registration and Listing under MoCRA, including product listing and biennial renewals. For the food industry, they facilitate US FDA Food Facility Registration and act as a US FDA Agent for foreign food facilities, ensuring compliance with FSMA. Buyers should note that the FDA does not issue a certificate of registration for food facilities, nor does it recognize third-party certificates; a registration number is issued instead.
Key Highlights
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Specializes in FDA registration, US FDA Agent services, and regulatory compliance for drugs, cosmetics, and food facilities.
Source
“They specialize in FDA registration, US FDA agent services, and regulatory compliance for various product types.”
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Assists with NDC Labeler Code requests, including SPL submissions via ESG or CDER Direct Portal.
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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Provides US FDA Agent services for foreign food facilities.
Source
“LMG also provides US FDA Agent service for foreign food facilities.”
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Offers support for Cosmetic Facility FDA Registration and Listing under MoCRA, including biennial renewal.
Source
“Cosmetic facilities registered with the FDA must renew the registration biennially.”
Certifications & Trust Signals
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Globally recognized FDA, CE Marking, and ISO consulting firm.
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 manufacturers requiring a US Agent
- Companies seeking FDA registration for drugs, cosmetics, or food facilities
- Businesses needing assistance with regulatory reporting and compliance
How engagement typically works
- Consultative support for regulatory processes
- Assistance with documentation and submissions
- Acting as a designated US Agent
Typical deliverables
- FDA Establishment Registration
- Drug Listing Submissions
- US FDA Agent Representation
- Cosmetic Facility Registration
- Food Facility Registration
- NDC Labeler Code Assignment Support
Good to know
- Best when engaging with FDA regulations for drugs, cosmetics, food, or medical devices.
- Requires clear documentation and information from the client for accurate submissions.
Pricing
Model:
Retainer
Public range:
Publicly listed: USD 349 - USD 1,000,000
Notes:
Pricing varies significantly by service type, with listed examples including USD 349, USD 399, USD 649 for various drug-related services and $1,000,000 for cosmetic facility registration.
“Pricing: USD 349; USD 649; USD 649”
HQ:
Aurora, USA
Languages:
English, Spanish
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
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:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting
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 preparation and submission of specific forms (e.g., 'NDC Labeler code request SPL', Form FDA 2656, Form FDA 2657, Form FDA 2658) via designated portals (ESG or CDER Direct Portal). Cosmetic facilities must register within 60 days of first engaging in manufacturing/processing or by July 1, 2024. Registration updates are required within 60 days of changes. Cosmetic registrations must be renewed biennially.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Drugs, Cosmetics, Food Facilities, Medical Devices
Registration Support
Yes
US Entity State
Illinois
Recall Support
No
Inspection Support
No
Emergency Contact24x7
No
