Life Sciences

Comprehensive advice to companies from the life sciences and healthcare sectors.

In one of the most regulated sectors where the branches of public and private law intertwine, we offer a highly specialized sectoral advisory service providing agile solutions and answers with added value.

Our lawyers have extensive experience in offering comprehensive and multidisciplinary advice to companies in the pharmaceutical, medical devices, biotech, healthtech, consumer healthcare, phytosanitary and agrochemical, and veterinary sectors. They also advise investment funds focused on the health sector, hospitals (private and public), clinics, foundations, institutions dedicated to research, and healthcare companies.

Accompanying in all stages of a product’s life cycle

We accompany our clients in all stages of a product’s life cycle (e.g., medicine, special medicine, medical devices and cosmetics), applying the multidisciplinary approach required: commercial, contractual, administrative and regulatory law, competition law, intellectual and industrial property, IT, data protection, labor and compliance.

Research stage: clinical trial agreements; research and development agreements; product research licensing agreements (in & out); pre-litigation and litigation issues concerning patents, trademarks, trade secrets, know-how and unfair competition; and designing regulatory structures.
Manufacture and distribution stage: manufacturing and supply agreements; quality agreements; pharmacovigilance agreements; agreements with QPs (both from a regulatory and labor perspective); and transport and logistics agreements.
Marketing stage: proceedings to obtain marketing authorizations; special proceedings for authorizing medicines; licensing agreements; co-promotion agreements; post-authorization studies; financing regimes and pricing; designing marketing strategies depending on the product type and category and the restrictions linked to the category (sale to chemist stores and hospitals), and public tenders.
Promotion stage: implementing and validating discount policies from a regulatory and a competition law perspective; reviewing and validating promotional material and actions (including medical checks), which includes advising from the perspective of the applicable regulations as well as on compliance with the different ethics codes applicable to each product type; interacting with health professionals; and designing and implementing compliance policies.

M&A transactions

Advising companies from the healthcare sector and private equity and venture capital institutions on negotiating and implementing all types of M&A transactions, including joint ventures, mergers and acquisitions, investments, exits and corporate restructurings.

Litigation

We represent our clients in civil and administrative proceedings against competitors and before public administrations, ministries, agencies, complaints committees and other government bodies.

In the news

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