Gap Analysis for MoCRA Registration

Before submitting information to the FDA, it’s essential to know if your cosmetic product files are complete and compliant. Sobel’s Gap Analysis for MoCRA registration reviews your documentation in detail, identifying missing elements and inconsistencies so you can correct issues early and ensure a smooth path to FDA approval.

For who?

A thorough gap analysis helps you avoid rework, prevent delays, and move toward MoCRA registration with confidence.

Why do you need this service?

Identifying documentation gaps before submission reduces the risk of rejection, rework, or costly delays during FDA review.

A complete, well-structured file increases your chances of a smooth FDA registration process under MoCRA.

Expert validation gives your team clarity and confidence, making sure nothing critical is overlooked.

Let us guide you through your MoCRA registration

Sobel provides the regulatory expertise you need to prepare accurate submissions. Our support helps align your operations with FDA requirements for cosmetic products.

Count on Sobel as your partner to achieve compliance and a smoother U.S. market entry.

Document Request

We request all product documentation needed for analysis.

Documentation Review

Evaluation of technical files, including formulation data, claims, safety records, labeling content, and facility details.

Gap Identification

Evaluation of technical files, including formulation data, claims, safety records, labeling content, and facility details.

Gap Analysis Report

Delivery of a detailed report highlighting non-conformities and proposed corrective actions.

Related
Services

We take care of the compliance challenges, so you can concentrate on expanding your cosmetic brand. Beyond gap analysis, Sobel provides additional services to support your cosmetic compliance journey:

Cosmetic FDA Package

Registration, label review, and safety substantiation for full regulatory compliance.

Facility Registration & Product Listing

Registration of cosmetic companies with the FDA under the new regulations.

Cosmetic Registration

Cosmetic Registration and Product Listing according to the FDA regulamentations.

Strengthen your cosmetic documentation before FDA submission

Submitting incomplete or misaligned files can jeopardize your U.S. market entry.

With Sobel’s Gap Analysis for MoCRA registration, you gain expert insights, actionable recommendations, and the confidence that your documentation meets FDA standards.

Talk to Sobel today to get ready for MoCRA registration.

Still have questions? Checkout our FAQ

1. What is a documentation gap analysis for MoCRA registration?

A gap analysis reviews your cosmetic product files before FDA submission to identify missing information, inconsistencies, or non-conformities that could cause delays. While it may seem like an extra step, this review acts as an important safeguard that saves time, money, and effort by preventing rework later in the process.

2. Why is a documentation review important before MoCRA registration?

Submitting incomplete or misaligned files increases the risk of rejection, rework, or enforcement actions. A documentation review ensures your submission is accurate, complete, and ready for FDA evaluation.

3. Do foreign cosmetic companies also need documentation analysis?

A documentation gap analysis is not a legal requirement for either U.S. or foreign companies. However, it is a highly valuable precaution, especially for international businesses adapting their files to FDA expectations. By reviewing documents in advance, companies reduce risks of rejection, avoid costly rework, and ensure a smoother path to MoCRA registration.

4. What is the main deliverable of a MoCRA documentation gap analysis with Sobel?

The deliverable is a Gap Analysis Report prepared by Sobel, highlighting non-conformities in your cosmetic product files and providing clear, actionable recommendations. Our team not only identifies potential risks but also explains practical solutions, giving your company the confidence that your documentation is aligned for MoCRA registration.

5. How does Sobel support companies during MoCRA registration?

Sobel provides expert document analysis, prepares a detailed Gap Analysis Report, and offers guidance on how to prioritize updates so your files are MoCRA-ready before FDA submission. Beyond documentation review, Sobel also offers complementary regulatory services such as product registration, facility registration, and labeling compliance, guiding your company through the entire regulatory journey in the U.S. cosmetics market.