Blog
The European Biotech Act: A Turning Point for EU Health Biotechnology
Kelsey Lenoch explores the European Commission’s adoption of the European Biotech Act on 16 December 2025 and what it signals for the future of biotechnology in the EU.
Plain Language Summaries in Clinical Trials: Regulatory Requirements and Best Practice
Laura Erwin provides guidance on delivering clear, compliant plain language summaries for clinical trials, including regulatory and operational best practice.
Meet the Boyds team: Ami Patel PhD
Ami Patel PhD, Senior Director, Business Development & Product Development at Boyds, explains her background and shares insights into industry trends.
Individualized Therapies on the Rise: Reflections from the Duke-Margolis/FDA Workshop
Individualized therapies are reshaping drug development. Sabine Ruehle shares insights from the Duke-Margolis/FDA workshop on n-of-1, gene editing, and fit-for-purpose regulation.
ICH M4Q(R2): Key Changes to CTD Quality Modules 2.3 and 3
An overview of the ICH M4Q(R2) guideline, outlining key structural changes to CTD Quality Modules 2.3 and 3 and implications for future regulatory submissions.
Navigating the MHRA’s International Recognition Procedure
Developed by the MHRA following the UK’s departure from the EU, the IRP aims to bring life-saving medicines to UK patients.
How to accelerate regulatory reviews with an eCTD viewer
Following another successful major filing at Boyds, the benefits of incorporating an eCTD viewer tool into the Quality Control (QC) process are once again evident. In our latest blog from the Regulatory Operations team at Boyds, we outline those advantages and explains how such investment delivers value from the initial to the final review.
Latest FDA Regulatory Updates: Leadership, Rare Disease Evidence & New Initiatives
Kelsey Lennoch, Associate Director, Regulatory Affairs at Boyds, explores the latest developments and regulatory updates at the FDA and offers guidance for sponsors, clinicians, and scientists navigating this complex environment.