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. They offer expert guidance on FDA regulations, ISO certifications, and quality systems.
**Expertise & scope** * Mandatory FDA agent requirement for foreign food, drug, and medical device establishments marketing products in the USA. * US Agent serves as the communication channel for the FDA, including scheduling inspections. * Required for FDA food facility registration (Section 7) and drug establishment registration (requiring a DUNS number). * Facilitates FDA registration for foreign medical device establishments, including confirmation of receipt codes. * Provides FDA registration services for food, drug, medical devices, and cosmetics. * Offers FDA agent services as a requisite for completing foreign establishment registrations. * Assists with FDA food facility registration, including online forms and US FDA Agent services. * Supports medical device establishment registration, providing owner/operator numbers and later registration numbers (FEI). * Covers drug establishment registration for manufacturing, processing, packing, re-packing, and labeling activities, including NDC labeler code and drug listing. * Facilitates MoCRA registration for cosmetic products and establishments, including facility registration and product listing.
**Reputation / proof points** * Offers ISO 9001 Certification and ISO 13485 Certification services.
Additional information
Liberty Management Group provides FDA registration services, which are mandatory for food, drug, and medical device establishments marketing in the USA. For cosmetic establishments, registration under MoCRA is also a requirement. The company emphasizes that FDA registration is for the establishment itself, not for individual products, and does not imply FDA approval. They issue their own FDA Registration Certificate for client records, which can be verified on their website. For foreign establishments, having a US FDA Agent is a critical step to complete the registration process. Pricing for FDA agent and registration services varies by registration type.
Key Highlights
Acts as a US FDA Agent 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.”
Provides FDA registration services for food, drug, medical devices, and cosmetics.
Source
“LMG provides FDA registration services to Food, Drug, Medical devices, and Cosmetic Companies.”
Facilitates MoCRA registration for cosmetic products and 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).”
Offers 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
Offers ISO 9001 Certification and ISO 13485 Certification.
Source
“ISO CERTIFICATION ISO 9001 CertificationISO 13485 CertificationISO Certification CostISO ConsultantHow to Verify ISO Certificate”
Buyer Snapshot
Best for
Foreign food, drug, and medical device establishments needing a US FDA Agent.
Companies seeking FDA registration services for food, drugs, and medical devices.
Cosmetic manufacturers and processors requiring MoCRA registration.
How engagement typically works
Guidance on FDA regulations and quality systems.
Facilitation of registration processes.
Provision of US Agent services.
Typical deliverables
FDA Agent confirmation and communication.
Completed FDA establishment registrations.
FDA Registration Certificates (issued by LMG).
MoCRA facility registrations and product listings.
Good to know
Best when requiring a US-based entity to act as the FDA Agent.
Best when needing assistance navigating complex FDA regulations for market entry.
Pricing
Model: Custom pricing
Public range: Publicly listed: USD 349 - 649
Notes: Based on publicly listed information; final fees depend on scope.
Yes, acts as point of contact for scheduling inspections.
Onboarding Steps
Requires completion of online forms for specific registration types (e.g., Food Facility Registration Form, medical device registration form, drug registration form). Information needed includes facility details, product types, and US Agent information where applicable.