Our Solutions
At Sobel, we offer expert regulatory support to help your cosmetic brand achieve full FDA cosmetic compliance, including adherence to the Modernization of Cosmetics Regulation Act (MoCRA). Our team enables you to navigate the evolving U.S. regulatory landscape so your products meet all requirements — from facility registration to product listing, labeling, and safety substantiation.
FDA Cosmetic Registration & MoCRA Compliance Made Simple
Regulatory Compliance Solutions for the U.S. Cosmetic Market
Expanding your cosmetic brand to the United States is a strategic move—but one that comes with strict regulatory expectations.
As the largest cosmetics market in the world, the U.S. now requires full MoCRA compliance, including FDA facility registration for manufacturers, product listing for all marketed cosmetics, designation of a Responsible Person in the U.S., compliance with FDA cosmetic labeling requirements, systems for adverse event reporting and implementation of Good Manufacturing Practices (GMP).
Sobel simplifies the path to market by providing personalized FDA cosmetic registration services, ensuring your company avoids regulatory delays and stays compliant at every stage.
Our Services in Regulatory Compliance Solutions
Discover the key steps of the cosmetics regulatory process and how Sobel can support you.
Cosmetic FDA Package
Registration, label review, and safety substantiation for full regulatory compliance.
Update of GMP Manual
We help cosmetic manufacturers revise documentation for full compliance.
Safety Substantiation
Compilation of safety data to support cosmetic product compliance with MoCRA requirements.
Elaboration of Standard Operational Procedure
Get FDA- and GMP-ready SOPs for your cosmetics business.
Cosmetic Registration
Cosmetic Registration and Product Listing according to the FDA regulamentations.
Gap Analysis
Pre-registration review of cosmetic documents to identify gaps and guide compliance.
Facility Registration & Product Listing
Registration of cosmetic companies with the FDA under the new regulations.
US Agent Service
Representation of foreign cosmetic companies. Support and communication with the FDA.
Product Labeling (Review)
Expert support for label verification, gap assessment, and revision under the MoCRA.
Change in Cosmetic Registration
Support with FDA cosmetic registration changes, from documentation review to submission.
From toxicological risk assessment and safety substantiation to reviewing ingredient safety and ensuring label accuracy, we provide a full suite of regulatory solutions.
Our services are designed to reduce compliance risks, speed up time-to-market, check the alignment with MoCRA 2022 updates, support you during inspections and audits, maintain compliance throughout the product lifecycle.
We also assist international brands by acting as a U.S. agent for FDA cosmetic compliance, bridging the gap between your company and the FDA requirements.
With our deep knowledge of U.S. cosmetic regulations, MoCRA requirements, and FDA expectations, Sobel’s team helps brands confidently expand to the U.S. market—while saving time, reducing regulatory burden, and increasing trust with consumers and authorities alike.
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