Liberty Management Group
★★★★★
5.0
/ 5
•
35 reviews
Liberty Management Group is a leading US FDA agent and registration service provider for foreign food, drug, and medical device establishments. They offer expert guidance on FDA regulations, ISO certifications, and quality systems.
Liberty Management Group (LMG) is a premier US-based consultancy specializing in FDA regulations and quality system compliance for international businesses. They serve as a crucial US FDA Agent for foreign food, drug, and medical device establishments looking to market their products in the United States. LMG ensures seamless communication with the FDA, assists with facility registration, and helps navigate complex regulatory requirements. With extensive experience, LMG offers comprehensive FDA registration services for food facilities, drug establishments, and medical devices. They also provide support for cosmetic registrations under MoCRA. Their expertise extends to ISO certifications, including ISO 9001 and ISO 13485, and GMP compliance. LMG is dedicated to helping clients achieve regulatory approval efficiently and cost-effectively, positioning themselves as a trusted partner in global market access. Their services are designed to meet the mandatory requirements for foreign entities, including DUNS number verification for drug establishments and confirmation of registration details. LMG's commitment to customer focus and leadership in regulatory affairs makes them an invaluable resource for businesses seeking to enter or maintain compliance within the US market.
About
**Who they are**
Liberty Management Group is a US FDA agent and registration service provider for foreign establishments in the food, drug, and medical device sectors. They offer guidance on FDA regulations, ISO certifications, and quality systems.
**Expertise & scope**
* Mandatory FDA agent services for foreign food, drug, and medical device establishments marketing products in the USA.
* Guidance on FDA food facility registration requirements, including the need for a US Agent.
* Support for drug establishment registration, requiring a US Agent with a DUNS number.
* Assistance for foreign medical device establishments needing an FDA Agent for registration.
* FDA registration services for food, drug, medical devices, and cosmetics.
* Guidance on MoCRA (Modernization of Cosmetics Regulation Act of 2022) for cosmetic product registration and facility registration.
* ISO certification services, including ISO 9001 and ISO 13485.
**Reputation / proof points**
* Offers FDA registration and US Agent services starting from $349.
Liberty Management Group is a US FDA agent and registration service provider for foreign establishments in the food, drug, and medical device sectors. They offer guidance on FDA regulations, ISO certifications, and quality systems.
**Expertise & scope**
* Mandatory FDA agent services for foreign food, drug, and medical device establishments marketing products in the USA.
* Guidance on FDA food facility registration requirements, including the need for a US Agent.
* Support for drug establishment registration, requiring a US Agent with a DUNS number.
* Assistance for foreign medical device establishments needing an FDA Agent for registration.
* FDA registration services for food, drug, medical devices, and cosmetics.
* Guidance on MoCRA (Modernization of Cosmetics Regulation Act of 2022) for cosmetic product registration and facility registration.
* ISO certification services, including ISO 9001 and ISO 13485.
**Reputation / proof points**
* Offers FDA registration and US Agent services starting from $349.
Additional information
For foreign entities marketing food, drugs, or medical devices in the USA, appointing a US FDA Agent is a mandatory step. This agent serves as the primary communication channel with the FDA, particularly for scheduling inspections. For food facilities, the US Agent's information is crucial for completing the registration form, and they are responsible for any re-inspection fees. Drug establishments must provide their US Agent's name and DUNS number. Medical device establishments require an FDA Agent to confirm receipt codes during the registration process. Liberty Management Group provides these essential agent services, ensuring compliance with FDA communication protocols.
Key Highlights
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Provides mandatory US FDA Agent services for foreign food, drug, and medical device establishments.
Source
“FDA Agent is a mandatory requirement for foreign food, drug, and medical device establishments that market their product in the USA.”
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Offers FDA registration services for food, drug, medical devices, and cosmetics.
Source
“LMG provides FDA registration services to Food, Drug, Medical devices, and Cosmetic Companies.”
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Assists with MoCRA (Modernization of Cosmetics Regulation Act of 2022) compliance for cosmetic facilities.
Source
“FDA cosmetic facility registration, also known as MoCRA Registration, is a new FDA requirement that cosmetic product manufacturers and processors must register their facilities with the U.S. Food and Drug Administration (FDA).”
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Provides guidance and services for ISO 9001 and ISO 13485 certifications.
Source
“ISO 9001 CertificationISO 13485 CertificationISO Certification CostISO ConsultantHow to Verify ISO Certificate”
Certifications & Trust Signals
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FDA registration and US Agent services are available starting from $349.
Source
“Our fees for FDA Registration and US Agent service are USD 349/year, including a free certificate of FDA registration.”
Buyer Snapshot
Best for
- Foreign food, drug, and medical device establishments needing a US FDA Agent.
- Companies seeking FDA registration for food, drug, medical devices, and cosmetics.
- Businesses requiring ISO 9001 or ISO 13485 certification guidance.
How engagement typically works
- Service-based engagement for FDA registration and agent services.
- Guidance and support for regulatory compliance.
Typical deliverables
- FDA Agent appointment and communication.
- Completed FDA establishment registrations.
- FDA registration certificates (issued by LMG).
- Guidance on ISO certifications.
Good to know
- Best when requiring a US-based entity to act as an FDA Agent.
- Best when needing assistance with FDA registration for products entering the US market.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: USD 349/year for FDA registration and US Agent service.
Notes:
Fees for FDA registration and US Agent service start at USD 349 per year. Other services may have different pricing structures.
“Our fees for FDA Registration and US Agent service are USD 349/year, including a free certificate of FDA registration.”
HQ:
Aurora, USA
Languages:
English
Timezones:
UTC-6
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Registration Support:
Yes
Inspection Support:
Yes
Annual Renewal Support:
Yes
Annual Renewal Reminder:
Yes
Product Type:
food, drugs, devices, cosmetics
Additional us_agent_fda Details
Product Types
Food, Drugs, Medical Devices, Cosmetics
Registration Support
Yes
Inspection Support
Yes, as the FDA contacts the US Agent to schedule inspections.
Onboarding Steps
Requires completion of online forms for specific services (e.g., Food Facility Registration Form, medical device registration form, drug registration form). Information needed includes facility details, product types, and US Agent information.
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