OUR LIFE SCIENCES AND HEALTHCARE PRACTICE WORKS TO FACILITATE BUSINESS AND INNOVATION IN THE HEALTHCARE SECTOR. WITH EXPERTISE IN REGULATORY, TRANSACTIONAL, CONTRACTUAL, AND LITIGATION MATTERS, WE ARE THE IDEAL STRATEGIC PARTNER TO HELP YOUR COMPANY THRIVE IN THE COMPLEX AND DYNAMIC LANDSCAPE OF THE INDUSTRY.
We specialize in a wide range of regulated products, from medicines, advanced therapies, and biotechnology to medical devices, software, cosmetics, food, and medical cannabis. We also serve different types of health institutions, such as hospitals, clinics, laboratories, pharmacies and drugstores, health plans, insurance companies, and telehealth companies.
In the digital health segment, we provide strategic support to investors and startups, such as healthtechs, biotechs, and medtechs, which are growing due to technological innovations and an increasing demand for legal solutions to adapt their business models to current laws and regulations.
LIFE SCIENCES AND HEALTHCARE EXPERIENCE
REGULATORY PRE- AND POST-MARKET
Advisory and litigation experience on issues involving regulations of the Ministry of Health (MS), the National Health Surveillance Agency (Anvisa), the National Supplementary Health Agency (ANS), the Medicines Market Regulation Chamber (CMED), the National Commission for the Incorporation of Technologies into the SUS (Conitec), professional health boards (medicine, pharmacy, nutrition, psychology, nursing, physiotherapy, and veterinary medicine, among others), the National Technical Biosafety Commission (CTNBio), the Ministry of Agriculture and Livestock (Mapa), and others.
CONTRACTS
Drafting and negotiating contracts typical of the industry, such as manufacturing and supply, distribution, research and development, licensing and technology transfer, productive development partnerships (PDPs), Local Development and Innovation Program (PDIL), technological orders (ETECS), strategic alliances and cooperation projects, risk-sharing contracts, patient programs, management by Social Health Organization (OSS), public-private partnerships (PPPs), outsourcing, and provision of regulated services.
LICENSING AND INCORPORATION STRATEGIES
Strategies for incorporating technologies into the SUS and ANS, as well as setting drug prices and support for obtaining permits, operating authorizations, certificates of good practice and operating licenses, registration and post-registration of regulated products.
CLINICAL RESEARCH
Experience with ethical and regulatory approvals, protocols, contracts and consents for clinical research, as well as adapting to the new law on research with human beings (Law No. 14,874/2024).
COMPLIANCE
Corporate investigations related to allegations or reports of violations involving industry regulations and adaptation of internal policies to industry transparency rules.
M&A
Experience in mergers and acquisitions, investment rounds (private equity, venture capital, and corporate venture capital), health data-driven transactions, purchase and sale of health insurance portfolios, licensing of regulated assets, joint ventures and foreign investments in the industry.
DIGITAL HEALTH
Advice on drafting innovative legal models involving investments in or the structuring of healthtechs, medtechs, and biotechs, including telemedicine, software as a medical device (SaMD), artificial intelligence (AI), remote drug sales, blockchain, big data and analytics, tailor-made medical devices, 3D printing, electronic medical records, the Internet of Things (IoT), discount programs and new payment models.
HEALTH DATA
Support in demands involving compliance with ethical, health, supplementary health, and health data protection regulations, enabling data-driven businesses, prevention and management of security incidents, interaction with supervisory authorities, terms of use, and privacy policies.
SUPPLEMENTARY HEALTH
Drawing up and negotiating contracts to offer insurance or health plan benefits, medical-hospital or dental care, including via benefits administrators and underwriters. We also advise on price-fixing processes, structuring and resizing the healthcare network, tax management, technical management, out-of-court liquidation and compulsory sale or transfer of health plan portfolios. We also work on economic and financial suitability and on prior approval processes with the ANS for the transfer of control or portfolio.
INSTITUTIONAL AND GOVERNMENT RELATIONS
Legal advice for mapping industry opportunities for engagement with federal, state, or local entities, as well as associations.
RECALLS
Support in procedures involving evaluation and strategies for the recall of products regulated by Anvisa or Mapa.
PLANTS, SEEDS, AND GMOS
Consulting on access to Brazilian genetic heritage and associated traditional knowledge with benefit sharing, as well as work with the Genetic Heritage Management Board (CGEN), and advice on the protection and exploitation of cultivars and new plant varieties.
INTELLECTUAL PROPERTY
Protection, registration, and maintenance of assets, including trademarks, patents, industrial designs, domain names, software, and plant varieties (cultivars), among others. Drafting and review of intellectual property policies. Advice on creations and inventions by employees and contractors.
Labor, tax, and litigation advice.
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