Cosmetics, sanitizing products, medical devices, medicines and companies
Cosmetics, sanitizing products, medical devices, medicines and APIs, and companies — AFE and GMP certification.
Led by Karen Moraes- 01Assessment
Regulatory classification and feasibility at Anvisa
Feasibility and classification of your product before investing in registration. Applied to planning and to strategic insight aligned with regulatory certainty.
- 02Cosmetics
Cosmetics — notification, registration and adjustments
Notification (grade 1) and registration (grade 2) of personal care products, cosmetics and perfumes, plus any required adjustments.
- 03Sanitizing products
Sanitizing products — notification, registration and adjustments
Notification and registration of sanitizing products by risk grade, and adjustments to ingredients and target pests in Anvisa's Solicita system.
- 04Medical devices
Medical devices — notification, registration, post-registration and clinical evidence
Notification, registration and post-registration changes for medical devices, including software as a medical device (SaMD) and clinical evidence.
- 05Company
Good Manufacturing Practices certification (CBPF)
GMP certification for international manufacturers and for sanitizing product manufacturers.
- 06Company
AFE and health licenses
Company Operating Authorization (AFE) — the federal authorization required of manufacturers and importers — and the local health permit or license that is its prerequisite.
- 07Medicines
Medicines and APIs — compliance in every format
Compliance in every format, whether by notification or registration, DIFA and CADIFA. Documentation related to research and clinical evidence for safety and efficacy, and patient and professional package inserts.
- 08Medicines
Quality system and controlled medicines
Quality Manual and SOPs, plus documentation for dispensing controlled medicines.
- 09Commercial
Regulatory support for commercial management
Regulatory support for commercially sensitive content and competitor analysis, with infringement risk analysis applied to commercial and marketing practices.
- 10Company
Ongoing regulatory advisory and regulatory representation in Brazil
Monthly technical and regulatory support and representation for Anvisa matters in Brasília.
Every product and every company has its particulars. Talk to SUA for the details of the service you need.
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