European Union Life Sciences Regulatory

Our lawyers advise clients on the hierarchy of EU legislation, including regulations, directives, and guidance documents issued by the European Commission, the European Medicines Agency (EMA), and national competent authorities (NCAs). We help clients understand how centralized and decentralized procedures affect authorization pathways and product obligations.

We assist clients in determining whether a product qualifies as a medicinal product, medical device, in vitro diagnostic (IVD), or combination product under EU law. Our team provides guidance on centralized authorization procedures under Regulation (EC) No 726/2004, mutual recognition, and decentralized approvals, ensuring full compliance with the applicable frameworks.

We guide companies through the preparation and submission of dossiers, including Common Technical Documents (CTDs) and design dossiers for medical devices. Our lawyers assist in navigating the EMA’s Committee for Medicinal Products for Human Use (CHMP) and other review bodies to obtain marketing authorization efficiently.

We counsel clients on pharmacovigilance and medical device vigilance systems under EU law, including reporting obligations for adverse events and corrective actions. Our team also advises on promotional activities, ensuring that advertising claims are consistent with product labeling and do not breach the EU’s strict prohibitions on misleading information.

We provide counsel on the Clinical Trials Regulation (EU) No 536/2014, which harmonizes the authorization and supervision of clinical trials across the EU. Our lawyers help clients prepare trial applications, obtain ethics committee approval, and ensure ongoing compliance with safety reporting and transparency obligations under the EU Clinical Trials Information System (CTIS).

Our lawyers help clients reconcile data processing under the General Data Protection Regulation (GDPR) with clinical research requirements. We develop consent frameworks, manage data transfers within and outside the EU, and ensure compliance with both research ethics and privacy laws applicable to human subjects.

We counsel clients developing cell and gene therapies, tissue-engineered products, and other advanced modalities. Our lawyers help navigate the classification, authorization, and pharmacovigilance requirements for ATMPs under Regulation (EC) No 1394/2007 and related EMA guidance.

We advise companies on the regulatory treatment of software as a medical device (SaMD), AI-driven diagnostics, and connected health applications. Our European Union Life Sciences Regulatory practice ensures that digital health products comply with the Medical Device Regulation (EU) 2017/745 and the AI Act, maintaining both innovation and compliance.

We assist clients during inspections by the EMA, national competent authorities, and data protection regulators. Our lawyers prepare companies for audits, respond to findings, and manage investigations related to quality, labeling, or safety violations.

Our team represents clients in challenging adverse regulatory decisions, including refusals of marketing authorization, labeling modifications, or product withdrawals. We litigate before the European Court of Justice (ECJ) and national courts, seeking judicial review of administrative acts and enforcement actions affecting market access.