Our Life Sciences Regulatory practice covers all aspects of the development of medicinal products (including biologicals and advanced therapy products) and medical devices. We advise on clinical trials (GCP), market authorisations, regulatory exclusivity, manufacturing (GMP), supply chain management, pharmaco- and materiovigilance, distribution, marketing and promotion, compliance, relationships with healthcare professionals, market access (in particular pricing and reimbursement strategies), patient support programmes, parallel trade, tenders, and privacy and data protection.
We also assist clients with the design and implementation of a life-cycle management strategy, through a combination of regulatory provisions and patent rights.
We advise and represent clients in their dealings with EU and national regulatory authorities and, if necessary, before the EU and national courts. For many years, we have represented the headquarters and local entities of a number of global pharmaceutical and biotech companies in EU and cross-border litigation and coordinated their legal representation across the EU, using our network of specialised regulatory counsel in all Member States.
Our longstanding experience in the field of pharmaceuticals, biologicals and medical devices, covering a wide range of products, services and clients as well as dealings with regulators and competent authorities, enables us to develop efficient strategies at various levels and, if necessary, on several fronts.
Clients appreciate our in-depth knowledge of the applicable legal framework and decades-long experience in their fields, coupled with a unique combination of top-notch regulatory and patent expertise.