Companies in the life sciences sector operate within a strict but rapidly changing legal and regulatory framework. Therefore, we focus on providing regulatory advice and solutions throughout the life sciences life cycle, including:

• Strategic advice to regulated industries covers all aspects related to the development, manufacture and marketing of any product, such as: pharmaceutical products, medical devices, food, cosmetics, dietary supplements, agrochemical products, cannabis, among others.

• Counseling includes and discusses the following:

  • Market strategies and their implementation

  • Product development

  • Clinical research

  • Registrations

  • Conflict resolution

  • Negotiations

  • Inspection raids

  • Test data protection

  • Advice on labeling, advertising, and promotion

  • Adverse event reporting

  • Product recalls

  • Good manufacturing practices

  • Sanctioning processes

Our advice and support include, but are not limited to:

• Risks Related to Confusing or Misleading Use of Trade or Company Names

• Labeling, advertising, and promotion ​

• Hiring logistics, distribution, and transport services 

• Sanitary certificates and permits, such as the Certificate of Good Practice of Storage, Distribution, and Transport

• We work with the Intellectual Property team for trademark registration and promotion and advertising strategies. We have experience in trial trademark, patent, and data protection litigation. 

• We have won many highly complex patent litigations, including cases that have been appealed before the National Court of Justice, and litigation involving biological products and the entry of biosimilars into the market.

• Our team implements patent registration strategies to anticipate the problems that could arise in the commercial or litigious field, with a deep understanding of multi-jurisdictional issues.

• Our patent strategies include injunction requests and the impact of pricing mechanisms on the calculation of damages.

• Our practice includes advising on the regulation of R&D activities (including clinical trial requirements and management of claims arising from adverse outcomes) and due diligence and pre-marketing audits.

• Legal support for:

  • Permits to offer, sell or market 

  • Operating Permits

  • Technical Representation

  • Pharmacovigilance and Technosurveillance

• We were the pioneers in finally obtaining express pronouncements from the authorities in favor of the direct protection of test data during the process of obtaining commercial licenses of pharmaceuticals.

• Advice on corporate governance

• Fusions and acquisitions

• Strategic collaborations and obtaining licenses

• ​Preparation of complaints and administrative claims against possible irregularities committed

• Arbitration & Mediation

• Product liability representation

• Patent infringement

• Trade secrets

• Contracts