REGULATORY, LIFE SCIENCES & HEALTHCARE

Our firm has a team of lawyers, from different areas of the law, that provides integrated services to companies in the areas of pharmaceuticals, human and animal health products, food, and biotechnology. Services of this area include consulting services to hospital groups, health maintenance organizations (HMOs), and tobacco manufacturers. Specifically in the regulatory area we also render consulting services in the areas of gas, oil, cinema, and television.

We render advisory and litigation services to our clients in:

• Advertising, prescription and OTC pharmaceutical promotional material content and media, and representation in administrative proceedings before the respective competent authorities and in judicial proceedings;
• Interaction between the pharmaceutical industry with health care professionals, hospitals, clinics, class associations, professional councils, and patient organizations, and their respective contracts;
• Negotiation and elaboration of clinical study contracts in Brazil, including the respective research protocols and consent forms; contracts related to license, distribution, outsourcing, and transfer of market authorization of products subject to sanitary regulations;
• Pharmaceutical products price control regulations;
• Preparation and development of Codes of Conduct (Ethics Codes) and the respective training;
• Registration, maintenance, exclusion, and de-accreditation of hospitals and clinics from HMOs before the Supplementary Health Agency (ANS);
• Consulting services on clinical studies and post study supply of clinical study drugs to study subjects;
• Advertising, content and media related to promotional material, packaging, labels, and display related to tobacco products as regulated by competent authorities (ANVISA, NBCAL, IPEM, INMETRO, PROCON);
• Scope and competency limits of regulatory agencies; and
• Sanitary surveillance regulations, including those related to storage and distribution, and registration of medicines, health, and food products.