Our Team and Experience

The Brazil team is composed of experienced professional (Lawyers, Pharmacist and Technical Legal Regulatory Consultants) with over 25 years in the industry.

The company was founded in 2002, and since then has a successful track record in supporting international companies with:

• Product regulatory support in the development and registration of Pharmaceutical, Medical Devices, Cosmetic, Food and Agricultural products (National Health Agency – “ANVISA”, and the Ministry of Agriculture).

• Metrological Law: National Institute of Metrology, Standards, and Industrial Quality - “INMETRO”, Institutes of Weights and Measurements - "IPEMs".

• Consumer Protection (Consumer Protection Body - “PROCON”, Government Attorney’s Office, Regular Courts, and NGOs).

• Biotechnology (biosafety law on genetic engineering and biotechnology).

• Agreements (analysis and elaboration).

• Implementation of in country affiliates

Their objective is focused on assisting companies not only on administrative and/or legal procedures but, particularly, on preventive actions, by providing guidance as to the applicable norms and legislation, procedures to regularize products and corporations acting in the health-care area, the requirements from regulatory agencies, in particular in the sphere of ANVISA, the Ministry of Agriculture and INMETRO; follow-up and update of the health-care legislation, preparing legal advices on the legality of health-care norms, survey of international legislation, delivery of in-company training programs, as well as acting and providing guidance in the area of consumer protection (Procons, DPDC), with special emphasis on products subject to ANVISA and MAPA inspection.

ANVISA Agência Nacional deVigilância Sanitária, ANVISA SEPN 515. Bloco B, Edificio Omega, Brasilia DF- CEP 70.770-502 Telephone : 55 61 448-1000 The National Health Surveillance Agency (Anvisa) was established by Law 9.782, of January 26, 1999. The Agency is designated an autonomous agency operating under a special regime. This means that ANVISA is an independently administered, financially-autonomous regulatory agency, with security of tenure for its directors during the period of their mandates. Within the structure of Federal Public Administration, the Agency is linked to the Ministry of Health, under a Management Contract. The agency incorporated additional attributions: coordination of the National Sanitary Surveillance System (SNVS), the National Program of Blood and Blood Products and the National Program of Prevention and Control of Hospital Infections; monitoring of drug prices and prices of medical devices; attributions pertaining to regulation, control and inspection of smoking products; technical support in granting of patents by the National Institute of Industrial Property. The purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. The latter embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the same. In addition, the Agency exercises control over ports, airports and borders and also liaises with the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.