Anvisa Gap Analysis for Cosmetics in Brazil
Before submitting your cosmetic product to Anvisa, make sure your file is accurate, consistent, and fully compliant. Our Anvisa gap analysis for cosmetics reviews your documentation, highlights missing elements, and helps you strengthen your dossier for faster approval in Brazil.
- Cosmetic manufacturers preparing to register or notify products with Anvisa.
- International brands entering the Brazilian market with cosmetics.
- Companies needing a pre-submission review to identify regulatory gaps.
- Businesses seeking expert guidance to improve dossier quality and compliance.
Let Sobel handle your Anvisa gap analysis for cosmetics, identifying risks early so your submission is smoother, faster, and fully compliant.
Why do you need this service?
Submitting a cosmetic file to Anvisa without a prior review can result in delays or even rejection.
Our Anvisa gap analysis for cosmetics reduces these risks by checking your documentation against current regulatory requirements.
With a complete and well-structured dossier, you increase your chances of fast approval, avoid costly rework, and save time and resources.
Your pathway to Anvisa approval for cosmetics
Sobel provides the regulatory insight you need to strengthen your cosmetic file.
Our support helps connect your global operations with Anvisa’s compliance pathway.
Count on Sobel as your partner to align cosmetic documentation with Brazilian regulatory standards.
Related
Services
Work with Sobel to prepare your cosmetic documentation for Anvisa. Our team helps you identify gaps, resolve non-conformities, and improve dossier quality for smoother approvals.
We take care of the compliance challenges, so you can concentrate on expanding your cosmetic brand.
Registration and Notification
We support Anvisa registration and notification processes for manufacturers and importers.
Brazilian Regulatory Representative
We act as your regulatory representative and manage Anvisa registration and notification.
Internal Audit for Cosmetics Manufacturers
Be compliant with GMP and Anvisa before your next inspection.
Complete and compliant dossiers for Anvisa submissions
Sobel’s specialists review your documentation with precision, identifying non-conformities, organisational gaps, and risks that could delay approval.
With Sobel as your partner, you reduce risks, save time, and prepare your cosmetic product for long-term success in the Brazilian market.
1. What is an Anvisa gap analysis for cosmetics?
It is a structured review of your cosmetic product documentation to identify missing elements, inconsistencies, and risks before submitting to Anvisa.
2. When should I request a gap analysis?
Ideally before preparing your dossier for notification (Grade I) or registration (Grade II), so issues are solved early and delays are avoided.
3. Does Sobel correct my documentation during the gap analysis?
No. We identify non-conformities and provide detailed recommendations. The responsibility for corrections remains with the company.
4. What deliverables will I receive?
You receive a Gap Analysis Report with all findings, plus guidance on non-conformities and suggested improvements.
5. Can a gap analysis reduce Anvisa’s evaluation time?
Yes. By addressing inconsistencies and documenting non-conformities early, the submission is more complete—often leading to expedited evaluations by Anvisa.
