Karen Moraes
Partner · Pharma
Biomedical scientist and regulatory affairs analyst with over ten years in medical materials and equipment, cosmetics, sanitizing products and tobacco products.
Learn moreRegulatory consultancy in Brasília
The regulatory clarity your product needs to reach the Brazilian market.
We advise Brazilian, foreign and startup companies on Anvisa and MAPA matters — from product classification to registration, company operating authorization (AFE) and Good Manufacturing Practices certification.
BrasíliaAnvisa · MAPABrazil + InternationalSenior partners
Our practice
Confidentiality, expertise and translation
01
Confidentiality and ethics
Sound regulatory advice for Brazilian, foreign or startup companies in food, cosmetics, sanitizing products, medical devices and medicines interested in the Brazilian market. Representation for Anvisa matters in Brasília.
02
Subject-matter expertise
The advice you need so your idea complies with Anvisa's rules and is ready to enter the Brazilian market. Understand the procedures, requirements, timeframes and costs to regularize your product or your company.
03
Translators of knowledge
We bring regulatory knowledge to those working in new business, marketing or areas that interface with Anvisa's rules. We train your team with courses on labeling, process preparation and more, as needed.
What we do
Two regulatory practices
Pharma and Food, each led by a partner. Whichever the path, the first step is classifying your product.
Pharma practice
Cosmetics, sanitizing products, devices and company
Cosmetics, sanitizing products, medical devices, controlled medicines, AFE and GMP certification.
- Regulatory classification and feasibility
- Cosmetics — notification and registration
- Sanitizing products — registration and adjustments
- Medical devices — registration, post-market and clinical evidence
Food practice
Food, supplements, beverages and ingredients
Food, dietary supplements, beverages, ingredients, infant and enteral formulas, labeling and MAPA.
- Regulatory classification and feasibility
- Dietary supplements — feasibility and notification
- Infant and enteral formulas
- Imported food and beverages — compliance and labeling
Who signs
Founding partners, hands-on
SUA is led by its partners. The person you hire is the person who signs your process.
Ana Luiza Sauerbronn
Partner · Food
Nutritionist, MSc in Product Health Surveillance (INCQS/Fiocruz) and former Unesco consultant; twenty years of practice in food health regulations.
Learn moreOur values are truly our practice. We work under confidentiality agreements and act ethically, in both private and institutional relationships.
Next step
Shall we talk about your product's regulatory path?
Tell us about your product and your sector. We will respond within one business day with an initial reading of the way forward.