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Boyds’ Dr Katherine Bowen, Chief Regulatory Affairs Officer and Dr Eric Hardter, Director of Regulatory Affairs, explore some of the key changes and provide advice for drug developers navigating the complexities of the regulatory landscape.

MHRA publishes UK government’s response to public consultation on future routes to market for medical devices designed to modernise regulation

Boyds’ Dr Neil Fish, Chief Business Officer, and Dr Ami Patel, Senior Director, Business Development and Product Development, explore the real-world challenges of drug development – from early-stage planning to regulatory hurdles – and provide expert insights on how to avoid the common pitfalls associated.

The European Commission, participating Member States and the European Medicines Agency (EMA) have announced the launch of the first phase of the COMBINE Project 1 pilot.

The European Commission has announced plans to set up a dedicated expert panel in the field of orphan and paediatric medical devices.

In April 2025, the US Food and Drug Administration (FDA) announced plans to phase out animal testing requirements for development of monoclonal antibodies (mAbs) and other drugs, and instead rely on human-relevant methods, such as in silico and in vitro human-based systems, for safety testing.

In this expert guide, Chris Moore, Senior Clinical Project Manager at Boyds, shares 10 essential considerations for U.S. biotechs looking to set up successful clinical trials in Europe under the new Clinical Trials Regulation (CTR) and CTIS system.

The European Union (EU) has one of the most advanced regulatory frameworks for healthcare innovation in the world. However, this complexity can pose significant challenges, particularly when clinical studies involve more than one category of health technology.