Life Sciences & Healthcare

KLA’s Life Sciences & Healthcare practice goes beyond traditional regulatory advisory. We combine deep technical knowledge with strategic and commercial insight, identifying regulatory hurdles, mapping risks, and presenting viable alternatives to enable our clients to make decisions with confidence and agility.

We advise companies operating in highly regulated markets — pharmaceutical industry, medical devices, biotechnology, health insurers, hospitals, laboratories, healthtechs, and other sector players — throughout all stages of their products and services, from development to crisis management. We also assist companies outside the sector that are part of regulated supply chains, such as chemical manufacturers and suppliers of raw materials.
Our multidisciplinary team bridges sanitary regulation, strategic litigation, contracts, compliance, tax, corporate, and intellectual property, delivering an integrated, results-oriented legal approach.

SERVICES

  • Strategic regulatory advisory before ANVISA, ANS, sanitary authorities, CMED, CONITEC, CNS, and professional councils, with a focus on practical solutions and risk mitigation.
  • Legal support for obtaining, renewing, and regularizing licenses, registrations, and sanitary authorizations at federal, state, and municipal levels, with integrated work alongside specialized clearance agents.
  • Transfer of product registration ownership before ANVISA and ANS, including risk assessment and management of administrative procedures.
  • Clinical research, innovation, and biotechnology — support for sponsors, CROs, and research centers; representation before CEP/CONEP; and advice on advanced therapies, genetic resources, and technology transfer.
  • Regulatory litigation and administrative proceedings.
  • Product recalls and management of regulatory crises, from authority notification to reputational management and adverse event investigations.
  • Complex contracts in the healthcare and health insurance sectors.
  • Public bids, government procurement, PPPs, and PDPs in healthcare, from planning through contractual performance.
  • Regulatory compliance, ethics, and digital health — structured programs, internal investigations, and development of new business models and products in compliance with ANVISA, ANS, and other authorities.
  • Advertising and marketing of regulated products, including risk assessment and compliance with ANVISA regulations.

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