Life Sciences and Healthcare

Your life sciences and healthcare sector business on the hands of specialists

Ongoing innovation and responsiveness define the healthcare and research sectors, driving the need for legal counsel with deep industry insight and up-to-date regulatory expertise to effectively navigate complex and evolving challenges.

Demarest’s Life Sciences practice area offers comprehensive legal assistance across the entire value chain – from clinical research to pharmacovigilance – integrating in-depth regulatory proficiency with solid experience in transactional and M&A matters.

Our Healthcare team provides legal support to organizations operating in both public and private spheres, leveraging our regulatory acumen and thorough understanding of the interactions among suppliers, service providers, healthcare professionals, patients, and government authorities.

Our team advises a broad spectrum of industries within the Life Sciences & Healthcare sector, including:

• Pharmaceuticals (synthetic, biological, biosimilar, herbal, radiopharmaceuticals, dynamized and medicinal gases)
  
• Medical devices (equipment, in vitro diagnostic products, instruments, and software classified as medical devices)
  
• Cosmetics and personal care products
  
• Household sanitizers
  
• Food and beverages
  
• Tobacco products
  
• Cannabis-based products
  
• Pharmacies and drugstores
  
• Clinical research
  
• Biotechnology and biodiversity
  
• Agricultural inputs (pesticides, crop protection products, fertilizers, bio-inputs, seeds, and seedlings)
  
• Animal health (animal feed products and veterinary services)
  
• Hospitals, clinics, healthtech companies, and health insurance providers,
  

Life Sciences

Your business in Life Sciences in the hands of specialist

The Life Sciences sector is defined by constant innovation and dynamism. In this landscape, companies need reliable legal advice from specialized, up-to-date professionals who can address a wide range of demands.

We provide legal advice across the entire spectrum of Life Sciences, from clinical research to pharmacovigilance, combining regulatory expertise with transactional and M&A experience.

We advise a wide range of industries operating in the life sciences industry, including:

• Pharmaceuticals (synthetic, biological, biosimilar, herbal, radiopharmaceuticals, dynamized, and medicinal gases)
• Medical devices (equipment, in vitro diagnostic products, instruments, and software as medical devices)
• Cosmetics and personal care products
• Household cleaning products
• Foods and beverages
• Tobacco products
• Cannabis-based products
• Pharmacies and drugstores
• Clinical research
• Biotechnology and biodiversity
• Agricultural inputs (pesticides, crop protection products, fertilizers, bioproducts, seeds, and seedlings)
• Animal health (animal feed products and veterinary services).

Demarest has a multidisciplinary team of highly qualified specialists, readily available to address any legal matter in the sector.

Regulatory practice

• Guidance on the licensing, registration, transfer, and legitimization of establishments and products regulated by the Brazilian Health Regulatory Agency (ANVISA) and the Ministry of Agriculture and Livestock (MAPA).
• Support with medicine pricing and the drafting of pricing information documents.
• Assistance in evaluating market access strategies for public and private healthcare sectors.
• Legal advice on clinical research, manufacturing, licensing, sale, distribution, advertising, and post-market management of adverse events and recalls.
• Consulting on compliance and ethical standards of professional conduct.
• Advisory in technology transfers and technological collaborations, Public-Private Partnerships (PPPs), Productive Development Partnerships (PDPs), and Local Development and Innovation Programs (PDILs).

Administrative and judicial proceedings

• Legal advice aimed at preventing or resolving disputes involving regulatory matters in the sector.
• Representation in administrative or judicial proceedings at the federal, state, and/or municipal levels, including responses to infraction notices and writs of mandamus against acts of the government.

Transactional and M&A

• Legal advice on a broad range of strategic transactions at the national and cross-border levels, including M&A, post-acquisition integration, strategic partnerships, joint ventures, company incorporation, and investments or divestments in companies or assets.
• Legal assistance in accessing capitalization, financing, and initial public offerings (IPOs).

Contracts

• Drafting and negotiation of complex contracts, including supply, distribution, service provision, manufacturing, and supply agreements (MSA), full manufacturing, toll manufacturing, quality agreements, among others.

Compliance

• Legal advice on healthcare compliance, including internal investigations and analyses, prevention, and mitigation of conflicts of interest in interactions with healthcare professionals, patient associations, and other stakeholders.
• Advisory services in the promotion and marketing of regulated products and services.

Intellectual Property

• Legal advice on the licensing and assignment of intellectual property rights, technologies, product research and development, and emerging technologies.
• Drafting and negotiation of confidentiality agreements and partnerships with research institutions.
• Advice on strategies for the protection, registration, and maintenance of intellectual property assets, such as patents, trademarks, industrial designs, Freedom to Operate (FTO) analyses, and the protection of cultivars and genetically modified organisms (GMOs) before the National Cultivar Protection Service (SNPC).
• Legal advice on administrative, civil, and criminal measures involving intellectual property rights infringements.

Government contracts and public procurement

• Legal advice to companies operating in Life Sciences across all aspects of contracting with the Federal Government, including traditional public procurement and innovative partnership structures.
• Drafting and negotiating proposals, reviewing qualification documents, and challenging public notices.
• Assistance in complex contractual models, such as PDPs, PPPs, and risk-sharing agreements, and in ensuring compliance with health regulations and local content requirements.

Healthcare

Legal advice in the healthcare and supplementary health sectors, grounded in an in-depth understanding of the relationships among suppliers, service providers, healthcare professionals, patients, and government entities.

The global healthcare landscape is currently undergoing an unprecedented transformation, driven by patient demand for broader access to healthcare. Brazil is no exception.

The physician-patient relationship is clearly evolving beyond traditional in-person consultations. Technology platforms, data digitization, and interoperability have become essential to delivering healthcare services that are cost-effective, safe, efficient, and – above all – ethical. Remuneration models are shifting toward value-based systems, while vertical consolidation is increasingly viewed as a strategy to control costs, improve quality, and enhance efficiency.

Our extensive knowledge of the healthcare sector, its developments and trends, combined with our expertise in regulatory matters, enables us to support clients in navigating this complex environment and achieving their business objectives.

• Multidisciplinary team with expertise in healthcare, supplementary health, technology, innovation, and regulation.
• Legal advice for healthcare plan operators, benefit administrators, startups, healthtechs, hospitals, and clinics.
• Continuous monitoring of ANS resolutions and key industry trends, ensuring legal solutions aligned with best practices.

Key services

1. REGULATORY

• Legal and regulatory advice for healthcare plan operators, benefit administrators, sponsors, associations, startups, and healthtechs.
• Support with licensing procedures before government and regulatory authorities, including licensing, Brazilian Registry of Health Facilities (CNES) registration, and bringing products and healthcare facilities into good standing.
• Assistance in product structuring, network leasing, pricing, suspension of sales, resizing of healthcare networks, preliminary investigation notices (NIP), transfer of registration and portfolios, intervention, liquidation, and compulsory sale of portfolios.

2. TECHNOLOGY, INNOVATION, AND DIGITAL HEALTH

• Legal advice for startups and healthtechs on health data protection, software as a medical device (SaMD), artificial intelligence (AI) in healthcare, electronic medical records, and emerging business models.
• Support for digital health initiatives, including telemedicine, blockchain, big data, and interoperability.

3. CONTRACTS AND RELATIONSHIPS WITH PROVIDERS

• Drafting and negotiation of agreements between healthcare plan operators and providers, with attention to the social function of contracts and legal certainty, in compliance with Law No. 9,656/1998 and ANS regulations.
• Review and negotiation of agreements between operators and sponsors, including legal opinions on contracts.
• Structuring of partnerships and innovative projects to expand access to healthcare and optimize costs.

4. ADMINISTRATIVE AND JUDICIAL PROCEEDINGS

• Representation in administrative and judicial proceedings at all levels: Federal, state, and municipal.

5. COMPLIANCE, ESG, AND GOVERNANCE

• Legal advice on healthcare compliance, including internal investigations and analyses, and the prevention and mitigation of conflicts of interest in interactions with healthcare professionals, patient associations, and suppliers.
• Consulting on ESG practices, ethics, and corporate governance, aligned with industry requirements and market expectations.

Trust our team to assist you in navigating the regulatory landscape safely and efficiently, innovating through digital solutions, and securing the sustainability of your healthcare business.