Regulatory Law in the Health Area
Also known as Health Law, Regulatory Law in the Health Area includes a set of laws, decrees, ordinances, and resolutions, etc., at municipal, state and federal level and involves the working of numerous authorities the objective of which is to ensure the regulation, control and protection of the population’s health.
We uphold an interdisciplinary approach, in view of the interfaces with other areas of intellectual property, antitrust and compliance, with strong practice in the areas of medicines, biological products, active pharmaceutical ingredients, medical devices, cosmetics, food and agrochemicals. Our team also acts in the areas of judicial and administrative litigation linked to the subject.
We actively take part in work groups, associations and events seeking to predict and prepare our clients for the everyday challenges and opportunities that arise.
- Services related to the area
- Preparation, monitoring and management of aspects connected to health inspections and compliance with good manufacturing practices.
- Formation of companies, regularisation and renewal of activities before the authorities in the Brazilian market.
- Investigations and guidance for compliance with regulatory standards, including regulatory strategy for development, approval of new products, renewal and transfer of registrations.
- Evaluation of cases involving permissions and restrictions to advertising and promotion of products submitted to the Health [and Hygiene] Inspection System.
- Drafting of defences and appeals related to health and hygiene violations.
- Procedures for the import of regulated products.
- Clinical research and access programmes regulated by ethics and regulatory authorities.
- Assistance in the procedures for price approval by the Medicine Market Regulation Chamber (CMED).
- Participation in due diligences in the regulated industries.