Life Sciences and Healthcare

We provide ongoing legal advice across all stages of development, manufacturing and marketing of pharmaceuticals, medical devices/health products, food, cosmetics, supplements, agrochemicals, cannabis and veterinary products.

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Our advisory services include:

• Regulatory and market strategy and implementation.

• Product development and clinical research trials.

• Marketing authorisations and licences.

• Preparation for, and response to, inspections and regulatory requests.

• Pharmacovigilance and technovigilance; adverse events and product recalls.

• Good Manufacturing Practices (GMP) and administrative sanctioning procedures.

• Protection of test data.

• Labelling, advertising and promotion.

• Early dispute prevention, resolution and negotiations.

We provide comprehensive advice throughout the supply chain and go-to-market process, including:

• Trademark and unfair competition risks (confusing or misleading use of trade names or business designations).

• Labelling, advertising and promotion compliance.

• Contracting of logistics, distribution and transportation services.

• Permits and sanitary certifications, including Good Storage, Distribution and Transportation Practices Certificate (BPADT).

We work closely with our Intellectual Property team on trademarks, patents and test data, providing both protection and litigation services.

• Trademark registration and defence, and advertising strategies within the legal framework.

• Complex patent litigation (including biologics and biosimilars) and protection of test data; experience before higher courts, including the National Court of Justice.

• Preventive patent strategies anticipating commercial or contentious risks, with a multijurisdictional approach.

• Precautionary measures and analysis of the impact of price control mechanisms on damage calculations.

We advise on the regulation of R&D activities, including clinical trial requirements and management of claims arising from adverse events, as well as due diligence and pre-commercialisation audits.

Our legal support covers:

• Sanitary registrations, notifications and renewals.

• Operating permits and technical representation.

• Pharmacovigilance and technovigilance.

• Implementation of quality and management systems.

We were pioneers in obtaining express rulings from authorities recognising direct protection of test data in sanitary registration processes, and we play an active role in regulatory reforms concerning intellectual property and trade secrets.

• Corporate governance and compliance.

• Mergers and acquisitions (M&A).

• Strategic alliances and licensing.

• Filing of administrative complaints and claims for irregularities in regulatory processes.

• Arbitration and mediation.

• Product liability representation.

• Patent infringement.

• Trade secrets.

• Contractual disputes.