Your regulatory consultancy on matters relating to the Brazilian Health Surveillance Agency – ANVISA and to the Ministry of Agriculture and Livestock – MAPA.
Regulatory consultancy for food, cosmetics, sanitizing products, medical devices – medical equipments, materials for health use, orthopedic implants and in vitro diagnostics – to the Brazilian market.
We advise, teach, develop strategies and regulate products subject to health surveillance.
Confidentiality and ethics. Safe regulatory assistance for a Brazilian, foreign or startup company in the area of food, cosmetics, sanitizing products or medical devices interested in the Brazilian market. Representation for Anvisa affairs in Brasília, if necessary.
Expertise in the matter. The assistance you need to make your idea be on agreement to Brazilian Health Regulatory Agency – Anvisa rules and able to enter the Brazilian market. Know the procedures, requirements, deadlines and costs for regularizing your product or company at Anvisa. Knowledge and experience that allow you to plan and make decisions consciously and safely.
Knowledge translators. We bring Anvisa regulatory knowledge to anyone working in new business, marketing or to those who need to seek assertive solutions in other areas with Anvisa's interface and rules. We qualify your team with courses on labeling, process elaboration, among others, according to your demand.
Have an objective and complete report of product diagnosis in Anvisa rules. According to the product’s classification in the category, subcategory, risk class or other classification of the product in Brazil, find out the procedures and rates necessary for its regularization. Ideal service to make your choices in new businesses in the Brazilian market
Have a technical assessment of your product formulation and labeling. Brazilian legislation brings some restrictions, limitations and even prohibitions on the use of certain ingredients and inputs in the formulation. We evaluate your formulation and suggest adjustments, if necessary. Ideal for new product in research and development stage.
We do your AFE dossier. AFE is a federal authorization issued by Anvisa, required for Brazilian companies that manufacture, import, distribute, sell products subject to health surveillance (except food). The prerequisite is the health license or permit issued by the local health surveillance service. If you do not have a license or a health permit, we can also guide you through this step.
We do your registration request dossier to Anvisa. Enteral formula is a food product category regulated and regulated by Anvisa, whose are intended for nutrition for patients who are fed by tube or orally with a liquid diet. Nutrition, be it standard, modified or specific diet therapy. We indicate the necessary documentation and information and elaborate the dossier in order to avoid demands and rejections.
Complementary information: Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.
We do your registration request dossier to Anvisa. Infant formula is a product category intended for feeding babies and newborn children up to 3 years, formulation without specific therapeutic or dietary indication. We indicate the necessary documentation and information and elaborate the dossier in order to avoid requeriments and rejections.
Complementary information: Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.
Cosmetic products need to be regularized with Anvisa through notification or registration dossier, depending on the degree of risk of the product. For both cases, we indicate the necessary documentation and information and elaborate the dossier in order to avoid requirements and rejections.
Complementary information: Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.
Sanitizing products (household cleaners), the popular cleaning products, need to be regularized with Anvisa through notification or registration processes, depending on the product’s risk class. For both processes, we indicate the necessary documentation and information and elaborate the processes in a more objective way in order to avoid demands and rejections.
Complementary information: Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.
Medical devices are products used for diagnosis, therapy, prevention, treatment, in the medical, dental, laboratory and hospital areas and it is regulated by Anvisa in Brazil. We elaborate the dossier to Anvisa in an assertive manner, indicating all necessary documentation, as well as doing its critical analysis. Thus, we speed up the technical analysis with Anvisa so that your product is fit for the Brazilian market.
Complementary information: Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.
Product in capsule, tablet, among other pharmaceutical forms to supplement the diet of healthy people needs to comply with Anvisa standards and be notified to Anvisa. We make an assessment of the formulation, mandatory labeling statements (in Portuguese), and all documents to notify Anvisa.
Complementary information: Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territor
We exist to find a regulatory solution with legal certainty and a scientific technical base. Work to deliver our best.
We think outside the box, expanding possibilities and solutions. We act on the same theme frequently in different realities, mostly in medium and high complexity subjects. We develop differentiated and own knowledge. We learn and teach all the time.
Being part of the connection that connects healthcare entrepreneurs and consumers is a great joy. Working with Anvisa's rules, a highly qualified regulatory agency, gives a greater meaning to what we do: working with prevention and promoting the health of all.
Our value is truly our practice. We work with a confidentiality agreement and operate based on ethics, private and institutional relations.
pHARMA
Biomedical analyst of regulatory affair with more than ten years of experience in regularizing medical device, sanitizing and smoking products. Deepened experience in regularizing companies from all areas subject to health surveillance with experience in auditing certification in Good Manufacturing Practices (GMP) nationally and internationally. Strategic thinking for problem solving and high management skills.
FOOD
Nutritionist, MSc Product Health Surveillance by INCQS / Fiocruz and specialist in public management and government relations. Regulatory affair analyst with experience in the public and private sectors, respecting the legal and ethical distance between them. Former consultant by Unesco working in food registration at Anvisa. Twenty years of practice of Brazilian food regulation.