Life Sciences & Healthcare

Life Sciences & Healthcare

We specialize in advising on regulatory, contractual, and litigation matters, and provide support for various other practices in mergers and acquisitions, internal investigations, and judicial disputes. With experience based on a diversified portfolio, our team serves investors, biotechnology companies, pharmaceutical and medical device companies, health service providers and health techs, as well as other health-related companies involved in cosmetics, toiletries and personal care products, food and beverage, drugstores, fertilizers and pesticides, seeds and seedlings, veterinary products and supplies, hospitals, health insurance, and digital health.

Our professionals’ expertise stands out in regulatory, transactional, contractual and litigation matters related to the life sciences and health sectors

Our main services

We represent companies in mergers and acquisitions, asset sales, purchase and licensing transactions, joint ventures, due diligence, and foreign investments in the sector;

We have worked on cases involving the Ministry of Health, the National Supplementary Health Agency (ANS), the National Health Regulatory Agency (Anvisa), the National Health Council (CNS), the Drugs Market Regulation Chamber (CMED), the National Commission for Incorporation of Health Technologies (Conitec), the Brazilian Federal Police, and other entities;

We can assist you with processes related to obtaining permits, authorization and operating licenses, the registration and post-registration of health agency-regulated products, and in the request for transferring registrations. Our experts are also experienced in incorporating new technologies into the National Unified Health System (SUS) and the ANS, drug pricing, obtaining authorization for health insurance companies and compulsory sales of health insurance portfolios, as well as financial and operational compliance in regard to consent processes with the ANS for transferring control or portfolios of health insurance companies;

We advise on issues related to promoting and marketing regulated products, and the rules of the Brazilian Advertising Self-Regulating Council (Conar);

We can assist your company in drafting and negotiating contracts typically seen within the sector – such as supply, distribution, agency, research and development, licensing, technology transfer and clinical research contracts, as well as contracts between companies and health insurance companies regarding employee healthcare benefits. We also assist with various types of partnerships, including public-private partnerships (PPPs) and product development partnerships (PDPs) in the health, training, technical services and process outsourcing sectors;

We support your company and advise on issues of plant variety protection, in addition to the developing and protecting of new plant varieties, including GMOs;

We are experienced in representing companies in proceedings before the health, agriculture, and livestock authorities at the federal, state, and municipal levels, including defending clients in regard to violation notices, inspections, and judicial proceedings involving the industry;

We act in recall procedures for regulated products and product liability issues;

We can assist you in preparing and negotiating the terms of hospital and dental assistance contracts, as well as creating models for benefit operators and administrators, insurance stipulators, associations, and others;

Our experts provide support to health techs, including in data protection and complying with applicable regulations, e-health, telemedicine, blockchain, big data & analytics, artificial intelligence (AI) in health, custom medical devices, 3D printing, electronic health records and registries, Internet of Things (IoT), discount programs and new payment models;

We advise on healthcare compliance issues, including conducting internal investigations, analyzing and reviewing policies and codes of conduct, and acting on ethical issues involving healthcare professionals.

Awards and Recognitions

Chambers Brazil Healthcare: Regulatory (2021 – 2022);

Chambers Brazil Life Sciences (2021 – 2022);

The Legal 500 Life Sciences (2021).

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