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.