LIFE SCIENCES & HEALTHCARE

Our Life Sciences & Healthcare practice combines experience and a vast history of our professionals in leading and multidisciplinary cases involving companies in this sector in the Brazilian market.

The familiarity of our team with the day-to-day issues of the regulated industry allows us to quickly assimilate the goals and challenges faced by customers to develop tailored and efficient solutions, either preventively or reactively.

Our team brings together leading professionals in the areas of health regulatory law, intellectual property, public law, contracts, public procurement and policies, and compliance, allowing a comprehensive approach to commercial, advisory and litigation matters.

Responsive to the peculiarities of the regulated industry, we advise national and multinational companies on pharmaceutical products, medical devices, food and beverages, biodiversity and biotechnology, cosmetics, healthtechs, telemedicine and healthcare services, among others.

 

Our services include:

 Establishing companies and structuring, regularizing and renewing activities with respect to the Brazilian market authorities;

  • Preparing, monitoring and managing aspects related to health inspections and compliance with Good Manufacturing and Quality practices;
  • Drafting and advising on contractual issues, considering the specifics of the sector;
  • Consultancy and administrative and judicial litigation, involving authorities that regulate the sector (such as INMETRO, IPEMs and CONAR);
  • Planning, implementing and monitoring the product introduction cycle in the Brazilian market, post-entry obligations, recalls and product liability;
  • Accessing and incorporating high-cost technologies into the Brazilian public and private health systems;
  • Importation procedures for regulated products;
  • Clinical research and access programs regulated by ethical and regulatory bodies;
  • Developing and implementing Compliance Programs, guidance and training on policies and procedures;
  • Investigations and guidance for compliance with regulatory standards, including regulatory strategy for new product development and approval;
  • Assessing cases involving permissions and restrictions on advertising and promotion of products submitted to the Health Surveillance System;
  • Advising on price approval procedures by the Pharmaceutical Market Regulation Chamber (CMED);
  • Advising companies on participation in bidding procedures, with the preparation of requests for clarification, challenges to public notices, appeals, including assistance during the holding of public sessions by the bidding organization;
  • Assisting in negotiations with the Ministry of Health related to the direct purchase of medicines, as well as in the structuring of innovative contractual models;
  • Consultancy and litigation (administrative and judicial) involving questions and assessments by the Ministry of Agriculture and other agricultural defense authorities;
  • Assisting in Research and Development projects involving Genetically Modified Organisms and respective procedures for accessing genetic heritage.