The European pharmaceutical and biotechnology field this year is undergoing one of the most significant transformations in several decades. For
After years in the making, the EU Pharma Package is closer to adoption than ever. In this week’s newsletter, we
We work with pharmaceutical companies on EU policies affecting medicines development, regulation, market access and the operating environment for the sector. We support companies navigate EU pharmaceutical legislation, regulatory frameworks for clinical research, incentives for innovation and the policies shaping Europe’s competitiveness in life sciences.
EU regulation directly affects how medical technologies are developed, certified and brought to patients. Our work covers the implementation and revision of MDR and IVDR, clinical evidence requirements, conformity assessment procedures and the practical challenges companies face when bringing technologies to patients.
Europe’s ability to attract healthcare R&D depends heavily on policy choices around funding, regulation, clinical research and innovation ecosystems. We support companies in understanding how EU priorities affect their research activities, help secure EU funding, and make the case for a stronger environment for healthcare research.
We advise companies on the European rules determining how health data can be accessed, shared and used, focusing on policies such as the European Health Data Space, data governance, digital health regulation and the practical impact of new requirements on healthcare businesses. We help companies define their positions and engage with policymakers shaping Europe’s approach to health data.
Biotech is increasingly central to Europe’s competitiveness in healthcare innovation. We work with biotech companies on EU debates affecting advanced therapies, biotechnology regulation, research incentives, and policies shaping Europe’s position in global life sciences.
Strong intellectual property rights determine whether Europe remains an attractive location for healthcare innovation. We advise healthcare companies on EU policies affecting the protection of intellectual property rights, including patents, R&D investment, technology transfer and market exclusivity.
The European pharmaceutical and biotechnology field this year is undergoing one of the most significant transformations in several decades. For years, the EU has been encountered with an innovation-access paradox. In other words, the Old Continent was home to first class research, but it was falling behind in market
While some see the agreement on the text of the Critical Medicines Act as a victory for patient safety, a deeper analysis shows a complex industrial change that attempts to balance between relatively high costs of European manufacturing and the uncertain security of global supply chains. The political agreement
After years in the making, the EU Pharma Package is closer to adoption than ever. In this week’s newsletter, we are breaking down the key consequences of its likely implementation. Pharma Package at the Door: Healthy Regulation or the Innovation Virus? The halls of the EU institutions are filled