Renata Rothbarth

Life sciences and healthcare / Technology / Public and regulatory law / Venture capital and startups

Since 2013, Renata has been assisting investors, leading and emerging companies in a wide range of contractual and regulatory issues relating to pharmaceuticals, biotechnology, vaccines, medical devices, and other health-regulated products. She also specializes in health innovation, clinical research, medical cannabis, advanced therapies such as genetic therapies, health insurance, drug pricing, public health, and public-private partnerships.

Her expertise lies in negotiating contracts that involve complex regulatory, business, and operational issues. This includes strategic alliances, research and development collaborations, technology licenses and acquisitions, productive development partnerships, pre-commercial procurement/technological orders, risk-sharing agreements, health data-driven transactions, manufacturing and distribution of regulated products, outsourcing, and clinical research.

In particular, Renata has developed extensive expertise in structuring innovative and complex payment/business models involving telemedicine, strategies for incorporating technologies into public and private healthcare systems, big data and analytics, artificial intelligence, virtual trials, genetics, precision medicine, wearable technologies, bioprinting, software as a medical device (SaMD), electronic health records (EHR), Internet of Medical Things (IoMT), medical discount and patient programs and health data privacy.

In addition to providing legal advice on mapping opportunities for engagement with federal, state or municipal entities and associations, Renata advises clients' business and legal teams on day-to-day issues. She actively works on the regulatory structuring of mergers and acquisitions or joint ventures involving pharmaceutical and medical device companies, health plan operators, for-profit and non-profit health service providers, healthtechs and others.

Renata also holds extensive experience with administrative and in-court proceedings involving Brazilian health authorities such as the National Sanitary Surveillance Agency (ANVISA), National Health Insurance Agency (ANS), Ministry of Health (MS) and the National Commission for Incorporation of Health Technologies (CONITEC).

Brazilian Association of Health Startups; International Bar Association; Brazilian Bar Association.