Souto Correa’s Life Sciences & Healthcare practice joins the experience and solid background of our professionals in pioneering and multidisciplinary proceedings involving companies of this industry in the Brazilian market.

Our team is well acquainted with the daily routine of the regulated industry, which allows us to quickly understand the goals and challenges faced by our clients and then develop customized and efficient solutions, preventively or reactively.

Our team comprises professionals of renown in the areas of sanitary regulation, intellectual property, administrative law, contracts, public tenders, public policies, and compliance. This allows us to take a comprehensive approach to commercial, consultancy, and litigation matters.

Attentive to the uniqueness of the regulated industry, we provide legal counseling to national and multinational companies in sectors such as pharmaceutical products, medical equipment, food and beverages, biodiversity and biotechnology, cosmetics, health techs, telemedicine, and health services. 

Our practice includes:

• Incorporation of companies and structuring, regularization and reaccreditation of activities before the Brazilian market authorities;
• Drafting, follow-up and management of aspects related to sanitary inspections and compliance with good manufacturing and quality practices;
• Drafting and counseling in contractual issues in compliance with specific requirements of the sector;
• Consultancy and administrative and judicial litigation involving authorities that regulate the sector (such as INMETRO, IPEMs and CONAR);
• Planning, implementation and monitoring of the product introduction cycle in the Brazilian market, post-entry obligations, recalls and civil liability;
• Access and integration of technologies into the Brazilian public and private health care systems;
• Import procedures for regulated products;
• Clinical research and access programs regulated by ethical and regulatory authorities;
• Drafting and implementation of compliance programs and guidance and training on policies and standards;
• Investigations and guidance for compliance with regulatory standards, including regulatory strategy for new product development and approval;
• Review of cases involving permissions and restrictions on advertising and promotion of products submitted to the Sanitary Surveillance System;
• Legal counseling on price approval procedures by CMED;
• Legal counseling to companies in their participation in tender procedures, including drafting requests for clarifications, objections to invitations to tender, and appeals, including counseling during the public sessions of the bidding body;
• Legal counseling on negotiations with the Ministry of Health related to the direct purchase of medicinal drugs, as well as on the structuring of innovative contractual models;
• Consultancy and administrative and judicial litigation involving queries and notifications by the Ministry of Agriculture and other agricultural defense authorities;
• Legal counselling on Research and Development projects involving GMOs and respective procedures for access to genetic heritage.