Cosmetics/MoCRA Compliance Services
At IUVO Consulting, LLC, we specialize in guiding cosmetic product companies through the complexities of FDA’s Modernization of Cosmetics Regulation Act of 2022 (MoCRA). It crucial to ensure your products meet the latest compliance standards.
Our Cosmetics/MoCRA Compliance Services
IUVO Consulting, LLC helps cosmetic companies navigate FDA MoCRA 2022 requirements to ensure full regulatory compliance.
IUVO Consulting
Facility Registration
MoCRA mandates that manufacturers and processors of cosmetic products register their facilities with the FDA and renew this registration every two years. We assist by:
01
Facilitating initial facility registrations to meet FDA requirements.
02
Managing biennial renewals to maintain compliance.
03
Updating registration information within 60 days of any changes.
Note: Certain firms may be exempt from these requirements
Need to register? Not sure if your firm is exempt?
Product Listing
Under MoCRA, Responsible Persons must list each marketed cosmetic product with the FDA, including product ingredients, and provide annual updates. Our team will:
01
Submit your firm’s product listings to the FDA.
02
Manage annual updates to keep your product information current.
03
Ensure timely submissions to prevent compliance issues.
Get assistance with your product listings now!
Adverse Event Reporting
MoCRA requires responsible persons to report serious adverse events associated with cosmetic products to the FDA within 15 business days. We provide support by:
01
Establishing protocols for monitoring and documenting adverse events.
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Preparing and submitting mandatory reports to the FDA promptly.
03
Advising on corrective actions to mitigate future risks.
Get support with creating and maintaining your Adverse Event Reporting.
Labeling Compliance
Accurate labeling is crucial for FDA compliance. The FDA has specific requirements regarding warnings, ingredient declarations, and claims on cosmetic product labels. Our services include:
01
Reviewing your product labels to ensure they meet FDA requirements.
02
Identifying necessary modifications to align with regulatory standards.
03
Assisting in the design or redesign of your product labels for clarity and compliance.
Have a label or ingredients that need review? Send it to us now!
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