Practice Areas

Regulatory

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handles regulatory matters and is experienced in
representing clients before national regulatory bodies

Chambers Europe, 2019

Our regulatory team assists its clients in all issues that inevitably arise during the life cycle of a pharmaceutical product and offers up-to-date advice such that clients can quickly adapt to the changing legal and regulatory framework.

In many years of working together with the innovative companies in the pharmaceutical fields, we have developed substantial experience in combining both regulatory and litigation strategies. This framework is increasingly complex and often involves working closely with our excellent competition team.  

Recent notable cases:

Representing leading companies specialized in supplying vegetable seeds for commercial cultivation on the issues arising from ministerial registration required in this particular sector


Representing a multinational pharmaceutical company in the Italian part of multijurisdictional litigation concerning Regulatory Data Protection relating to a chemotherapy medicine


Defending a global pharmaceutical company in litigation concerning the effects of orphan drug designation and its interaction with SPC protection, in relation to a blockbuster anti-cancer drug


Assisting a Swiss pharmaceutical company in negotiations with the Italian Regulatory Authority concerning the pay-back procedure


Representing a Swiss pharmaceutical company in litigation concerning the procurement of pharmaceutical products through public tender procedures


Representing and defending an Italian pharmaceutical company in litigation against major generic company concerning compliance with regulatory provisions applicable in the framework of the abridged procedure for the authorisation of a generic version of a blockbuster drug in the respiratory area

Regulatory - Trevisan & Cuonzo