The information and services you need to make your idea be on agreement to Brazilian Health Regulatory Agency - Anvisa rules and able to the Brazilian market.

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 the health surveillance of the state or municipality. We make an assessment of the formulation, definition of mandatory labeling statements (in Portuguese), revision of the labeling according to all applicable health rules and filling in forms for notification.

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