We have one of the largest specialist biotech teams in Europe supporting global biotech companies at all stages of development, innovation, and growth. Our clients are diverse and include therapeutics companies, suppliers of research tools, companion diagnostics, and other in vitro diagnostics and bio information solutions. Our expertise extends to broader applications of biotech across environmental, industrial, and agri-biotech.
With legal expertise grounded in scientific know-how, our support incorporates company formation, spin-out accelerator programmes, venture capital fundraisings, licensing and collaborations, clinical trials, and strategic alliances in addition to accessing capital markets and deploying intellectual property rights.
Clients value our long-held industry connections and our specialist sector expertise. Our global team is embedded in this industry with experience across many technologies, including vaccines, therapeutic proteins, monoclonal antibodies, immune-oncology, and cell-based therapies, gene therapies, and tissue-engineered products.
We are chosen by renowned biotech companies for our expertise in negotiating on pivotal IP licensing deals, resolving disputes with strategic partners, dealing with data privacy issues and avoiding competition/anti-trust risks. With our support, they push innovation boundaries and exploit commercial opportunities while remaining secure within relevant regulatory regimes.
Aktuelle News & Insights
Biotechnologie als Sicherheitsfrage: Warum Dual-Use-Kontrolle und lernende Regulierung über nationale Zukunftsfähigkeit entscheiden
EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
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EU and medicines supply issues (part two): Proposals for future measures
In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.
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Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
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Comparison of national measures to protect the supply of medicines and medical devices
Our international team has developed a practical guide that allows users to navigate different European jurisdictions, identifying medicines subject to supply restrictions, and understand manufacturers' obligations during shortages or product withdrawals.
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