Liberty Management Group
★★★★★
5.0
/ 5
•
33 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 food, drug, and medical device establishments.
**Expertise & scope**
* Guidance on FDA regulations, ISO certifications, and quality systems.
* FDA Agent services are mandatory for foreign food, drug, and medical device establishments marketing products in the USA.
* The FDA Agent serves as the communication channel for the FDA and can be contacted for scheduling inspections.
* For food facilities, the US Agent's name and DUNS number are required for registration, and they are responsible for re-inspection fees.
* For drug establishments, the US Agent must be a US-based company with a DUNS number.
* Foreign medical device establishments require an FDA Agent to complete registration and confirm receipt codes.
* Services include FDA registration for food, drug, medical devices, and cosmetic companies.
* FDA registration is mandatory for food, drug, and medical devices, and voluntary for cosmetics.
* FDA registration services include FDA agent services for foreign establishments.
* Assistance with FDA food facility registration and US FDA Agent services.
* Support for medical device establishments registering with the FDA, including obtaining an owner/operator number and later an FEI registration number.
* Guidance for drug establishments on registration, NDC labeler code, and drug listing.
* Support for cosmetic facility registration (MoCRA) and product listing, including facility registration renewal biennially.
**Reputation / proof points**
* Offers FDA registration services starting from $349.
Liberty Management Group is a US FDA agent and registration service provider for foreign food, drug, and medical device establishments.
**Expertise & scope**
* Guidance on FDA regulations, ISO certifications, and quality systems.
* FDA Agent services are mandatory for foreign food, drug, and medical device establishments marketing products in the USA.
* The FDA Agent serves as the communication channel for the FDA and can be contacted for scheduling inspections.
* For food facilities, the US Agent's name and DUNS number are required for registration, and they are responsible for re-inspection fees.
* For drug establishments, the US Agent must be a US-based company with a DUNS number.
* Foreign medical device establishments require an FDA Agent to complete registration and confirm receipt codes.
* Services include FDA registration for food, drug, medical devices, and cosmetic companies.
* FDA registration is mandatory for food, drug, and medical devices, and voluntary for cosmetics.
* FDA registration services include FDA agent services for foreign establishments.
* Assistance with FDA food facility registration and US FDA Agent services.
* Support for medical device establishments registering with the FDA, including obtaining an owner/operator number and later an FEI registration number.
* Guidance for drug establishments on registration, NDC labeler code, and drug listing.
* Support for cosmetic facility registration (MoCRA) and product listing, including facility registration renewal biennially.
**Reputation / proof points**
* Offers FDA registration services starting from $349.
Additional information
Liberty Management Group provides FDA registration services for various product types, including food, drugs, medical devices, and cosmetics. For foreign establishments, securing a US FDA Agent is a critical step in the registration process. The company emphasizes that FDA registration itself does not imply FDA approval of products or facilities; it signifies that the facility has met initial registration requirements. They also offer assistance with ISO certifications, such as ISO 9001 and ISO 13485. For cosmetic products, they support registration under the Modernization of Cosmetics Regulation Act (MoCRA), which mandates facility registration and product listing for most cosmetic products distributed in the US.
Key Highlights
-
Provides FDA Agent services, a mandatory requirement for foreign food, drug, and medical device establishments marketing products in the USA.
Source
“FDA Agent is a mandatory requirement for foreign food, drug, and medical device establishments that market their product in the USA.”
-
Offers FDA registration services starting from $349.
Source
“Our fees for FDA Registration and US Agent service are USD 349/year, including a free certificate of FDA registration.”
-
Supports FDA cosmetic facility registration (MoCRA) and product listing.
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).”
-
Provides guidance on ISO certifications, including ISO 9001 and ISO 13485.
Source
“They offer expert guidance on FDA regulations, ISO certifications, and quality systems.”
Certifications & Trust Signals
-
Acts as a US FDA Agent for foreign establishments.
Source
“FDA Agent is a mandatory requirement for foreign food, drug, and medical device establishments that market their product in the USA.”
-
Issues an FDA Registration Certificate for client records.
Source
“LMG will issue an FDA Registration Certificate for our clients for their records.”
Buyer Snapshot
Best for
- Foreign food, drug, and medical device establishments needing an FDA US Agent.
- Companies seeking FDA registration services for food, drugs, medical devices, and cosmetics.
- Businesses requiring guidance on FDA regulations and quality systems.
How engagement typically works
- Online form submission for registration services.
- Direct inquiry for service fees and assistance.
Typical deliverables
- FDA Agent confirmation and support.
- FDA establishment registration numbers.
- FDA registration certificates (issued by LMG).
- Guidance on ISO certifications.
Good to know
- Best when requiring a US-based entity as an FDA Agent.
- Best when needing assistance with FDA registration processes for US market entry.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: USD 349/year
Notes:
Based on publicly listed information; final fees depend on scope.
“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
Status:
listed
Services & Capabilities
Best 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:
devices
Additional us_agent_fda Details
Product Types
Food, Drugs, Medical Devices, Cosmetics
Registration Support
Yes
Inspection Support
Yes, acts as a point of contact for scheduling inspections.
Onboarding Steps
Requires completion of online forms for specific registration types (Food Facility Registration Form, medical device registration form, drug establishment registration form).
