Gap Analysis for Cosmetics in Brazil
Anvisa Gap Analysis for Cosmetics in Brazil
Preparing a cosmetic product for registration or notification with Anvisa requires more than assembling documents—it demands accuracy, consistency, and full alignment with Brazilian regulatory expectations. Any missing information or inconsistencies can delay your submission or lead to rejection.
Our Anvisa Gap Analysis service provides a critical review of your documentation, helping identify regulatory gaps and areas that need adjustment before submitting your product to Anvisa.
Whether your cosmetic is classified as Grade I (low risk) or Grade II (high risk), we help you strengthen your file for better submission outcomes.
How we support your Regulatory Gap Analysis
Our team performs a structured regulatory gap analysis for cosmetics in Brazil, reviewing technical and administrative documents based on your product’s classification and intended regulatory pathway.
We support both notification and registration scenarios:
For Grade I Products (Notification)
Review of product purpose and classification;
Verification of formula composition, stability data, and technical specifications;
Assessment of Portuguese labeling and required declarations;
Cross-checking documentation completeness based on Anvisa’s notification requirements.
For Grade II Products (Registration)
In-depth analysis of all required documents, including: safety and technical justification, microbiological and physical-chemical specifications, clinical or supporting test results (if applicable), term of responsibility and packaging and labeling review;
Evaluation of the company’s preparedness for the formal registration process.
At the end of the process, you receive a detailed report highlighting documentation issues, structural weaknesses, and suggestions for improvement, supporting your Anvisa submission readiness check.
Why do you need this service?
We check your product file against current Anvisa requirements for cosmetic compliance in Brazil, minimizing the risk of missing elements.
A complete, well-organized dossier increases your chances of a smooth review process and regulatory acceptance.
Our pre-submission review for Anvisa cosmetics helps your team correct issues before submission—saving time and resources.
We specialize in supporting companies through the cosmetic product Anvisa review process in Brazil. Our consultants bring hands-on experience in gap identification, documentation review, and strategic regulatory consulting for both local and international clients.
We tailor our approach to your product and business model, so your documents are not only complete, but also structured according to Anvisa’s expectations.
Need support with Anvisa Gap Analysis for cosmetics?
If your company is preparing to register or notify a product with Anvisa, a gap analysis is a smart first step. We help verify your file’s accuracy, identify risks, and improve your readiness for a successful submission.
Ready to strengthen your cosmetic product file before submitting it to Anvisa? Talk to our team and find out how our gap analysis can support your compliance journey in Brazil.
