With the enforcement of the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies operating in or exporting to the U.S. must meet new documentation and registration requirements.
But before submitting information to the FDA, how can you be sure your product files are truly ready?
At Sobel, we offer a focused Gap Analysis service for cosmetic product documentation, designed to help your team identify missing information, inconsistencies, or non-conformities before registration.
This step is key to avoiding delays, reducing rework, and ensuring a smoother path to compliance.
Our team performs a critical and structured review of your cosmetic product documentation, checking it against FDA MoCRA compliance requirements and best practices in regulatory filing.
What’s included in the Gap Analysis for cosmetics under MoCRA:
Documentation review: We evaluate the technical documentation you’ve prepared for FDA registration, including formulation details, product claims, safety data, labeling content, and facility information.
Gap identification: Through our cosmetic product file gap analysis, we detect missing elements, misaligned data, or formatting issues that may cause problems during submission.
Recommendations: Based on the findings, we deliver a detailed Gap Analysis Report highlighting non-conformities and proposing corrective actions.
Pre-registration support: We help you prioritize updates so your submission meets MoCRA expectations and is ready for FDA review.
This service is ideal for manufacturers, importers, and brand owners seeking a MoCRA readiness assessment for cosmetics.
Identifying gaps before submission minimizes the risk of rejection or delay during the FDA registration process.
A complete and aligned file improves your chances of a smooth FDA review under MoCRA.
With our structured FDA cosmetic registration gap assessment, your team moves forward with confidence.
At Sobel, we support companies preparing for the U.S. cosmetics market by validating their documentation before it’s submitted. Our experts understand the nuances of MoCRA documentation and provide practical insights that help you correct issues early.
Whether you’re launching a new product or adjusting your processes to meet FDA requirements, our regulatory document verification process gives you a clear starting point for compliance.
Let us help you evaluate your documentation with precision and objectivity. Our Gap Analysis for cosmetic products in the U.S. helps ensure you’re not leaving critical information behind.
Talk to us today and discover how our MoCRA gap analysis service can support your FDA registration journey.
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