MoCRA Registration & Compliance Services
Understanding the Modernization of Cosmetics Regulation Act (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law on December 29, 2022, grants the FDA increased authority to regulate the safety and quality of cosmetics in the U.S., transitioning from voluntary to mandatory compliance. This significant regulatory shift addresses long-standing concerns about ingredient safety, product quality, and good manufacturing practices in the personal care products industry.
At Qualitas, we specialize in helping businesses navigate MoCRA compliance. Our experienced consultants provide comprehensive guidance tailored to your operations, including product registration, product listing, safety substantiation, adverse event reporting, and GMP compliance. We monitor the latest regulatory updates to ensure your strategies remain adaptable and effective.
What’s included in our MoCRA Package?
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A comprehensive document per primary and secondary SKU iterations to include highlighted regulatory citations with annotated context, insights, and recommendations.
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A comprehensive document per formula outlining its composition in order of predominance supported by 2-3 (or more, if applicable) scientific citations outlining the formula’s safety status based on available scientific literature
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Gathering evidence using information from scientific publications and market data, and/or experimental studies (in silico, in vitro, ex vivo, in vitro, etc.) to substantiate individual claims and suggest other claims based on the formula.
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Listing of cosmetic products through the FDA Cosmetics Direct portal to be legally compliant with mandatory MoCRA requirements.
Our comprehensive MoCRA Essentials package is designed to ensure you have all the necessary support and guidance for smooth and effective compliance with the Modernization of Cosmetics Regulation Act.
$2,999
Per “Parent” SKU or Unique Formula SKU
$799
Per “Child” SKU or Additional Size Variation SKU
Volume discounts available
Speak to one of our MoCRA experts today.
Not sure where to start? Reach out to a member of our team, and we'll guide you through the process step by step. Whether you need assistance with SKU descriptions, labeling requirements, or any other aspect of compliance, our experts are ready to provide the support you need.