Our practice
Two practices, one standard of rigor
We organize the practice into two fronts — Pharma and Food —, each led by a partner. Whichever the path, the first step is the same: classifying your product.
Where to start
Not sure of the path? Start with a feasibility assessment.
Before registering, we assess what the product is in the eyes of the rules and whether the path is viable — with a report that guides the decision and avoids rework.
Pharma practice
Cosmetics, sanitizing products, devices and company
Cosmetics, sanitizing products, medical devices, controlled medicines, AFE and GMP certification.
Led by Karen Moraes- 01AssessmentRegulatory classification and feasibilityFeasibility and classification of your product before investing in registration.
- 02CosmeticsCosmetics — notification and registrationNotification (grade 1) and registration (grade 2) of personal care products, cosmetics and perfumes.
- 03Sanitizing productsSanitizing products — registration and adjustmentsRegistration of risk-grade-2 sanitizing products and ingredient/target-pest updates in Solicita.
- 04Medical devicesMedical devices — registration, post-market and clinical evidenceRegistration and post-market changes for medical devices, including SaMD and clinical evidence.
- 05CompanyGood Manufacturing Practices (GMP) certificationGMP certification for international manufacturers (except Mercosur) and for sanitizing-product makers.
- 06CompanyAFE and health licensesCompany Operating Authorization (AFE) and health license from the local health authority.
- 07MedicinesQuality and controlled medicinesQuality Manual and SOPs, and documentation for dispensing controlled medicines.
- 08CompanyOngoing regulatory advisory and representation in BrazilMonthly technical-regulatory support and representation for Anvisa matters in Brasília.
Food practice
Food, supplements, beverages and ingredients
Food, dietary supplements, beverages, ingredients, infant and enteral formulas, labeling and MAPA.
Led by Ana Luiza Sauerbronn- 01AssessmentRegulatory classification and feasibilityFeasibility assessment of food, supplements, beverages and ingredients before regularizing.
- 02SupplementsDietary supplements — feasibility and notificationFrom feasibility assessment to notification of dietary supplements with Anvisa.
- 03FoodInfant and enteral formulasCompliance assessment and registration of infant and enteral formulas with Anvisa.
- 04FoodImported food and beverages — compliance and labelingCompliance and labeling of imported food and beverages (Anvisa, MAPA, SNVS).
- 05IngredientsIngredients, novel foods and functional claimsFrom technical specification to clinical study and consultation with Anvisa for claims.
- 06FoodLabeling and advertisingLabel preparation and review, and risk analysis of advertising violations.
- 07FoodProduct development (R&D)Regulatory support for developing supplements and food, from the formulation stage.
- 08CompanyOngoing regulatory advisoryMonthly regulatory support for a portfolio of food, supplements and ingredients.
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.