FDA Compliance Made Simple
Expert regulatory support for conventional and otc cosmetic establishments, so you can focus on your business.
VIEW OUR SERVICESU.S. Agent & FDA Cosmetic Compliance Services
MoCRA Facility Registration
FDA cosmetic facility registration for domestic and foreign manufacturers under MoCRA, including biennial renewals and account setup.
➧ Request Registration
Cosmetic Product Listing
Electronic product listing submissions including ingredient disclosure, labeling compliance, and regulatory documentation review.
➧ List Your Products
U.S. Agent Representation
Official U.S. Agent appointment for foreign cosmetic facilities serving as the FDA communication and compliance liaison.
➧ Appoint U.S. Agent
Cosmetic Label Review
Detailed review of ingredient statements, warnings, net quantity, and principal display panel compliance with FDA cosmetic regulations.
➧ Get Label Review
Safety Substantiation Review
Assessment of toxicological data, ingredient safety files, and documentation required to demonstrate product safety under MoCRA.
➧ Ensure Compliance
Adverse Event Reporting Support
Implementation of serious adverse event reporting systems and timely FDA submission within the 15-business-day requirement.
➧ Set Up Reporting
FDA Inspection Preparation
Mock inspections, GMP readiness reviews, SOP audits, and regulatory gap analysis to prepare for FDA facility inspections.
➧ Prepare for Inspection
OTC Cosmetic / Drug Classification Review
Regulatory evaluation to determine cosmetic vs. OTC drug status including monograph and active ingredient assessment.
➧ Request Classification
Import Compliance & FDA Detention Assistance
Support responding to FDA import detentions, documentation correction, and regulatory remediation strategies.
➧ Resolve Import Issues
Regulatory Strategy & Ongoing Compliance
Long-term compliance advisory, regulatory updates monitoring, enforcement risk assessment, and strategic planning.
➧ Schedule Consultation
MoCRA Cosmetic Establishment Registration
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Product Listing
U.S. FDA Cosmetics Registration & Compliance
Planning to manufacture, export, import, distribute or sell cosmetic products in the United States? Review our FDA cosmetics information to better understand important registration, product listing, labeling and compliance considerations before entering the U.S. market.
Cosmetic Facility Registration
Learn about FDA cosmetic facility registration requirements and considerations affecting domestic and foreign establishments that manufacture or process cosmetic products for the U.S. market.
Cosmetic Product Listing
Review cosmetic product listing responsibilities and the information companies may need to maintain for cosmetic products marketed in the United States.
MoCRA Compliance
Understand key compliance responsibilities under the Modernization of Cosmetics Regulation Act of 2022, commonly known as MoCRA, including requirements affecting manufacturers and responsible persons.
Foreign Cosmetic Manufacturers
Companies in Europe, Asia, Latin America, Africa and other regions should understand applicable FDA requirements before exporting cosmetic products to customers, distributors and marketplaces in the United States.
Cosmetic Label Compliance
Proper product identity, ingredient declarations, net quantity, business information, warnings and marketing claims can be critical components of U.S. cosmetic labeling compliance.
FDA Regulatory Support
Experienced FDA regulatory consultants can assist manufacturers, exporters, importers and distributors with registration, product listing, labeling and other U.S. compliance responsibilities.
Preparing Cosmetics for the U.S. Market?
Read our cosmetics compliance resource to learn more about FDA requirements and regulatory services available to domestic and foreign cosmetic companies.
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