Blog

To mark Ada Lovelace Day, we spoke to Katherine Bowen, Senior Director of Regulatory Affairs at Boyds, about the inspiration behind her STEM career, how she overcame challenges along the way, and ways to encourage more women to work in STEM.

In the fast-paced world of drug development, navigating the regulatory landscape can feel like running a marathon with hurdles at every turn. One of the critical checkpoints in this race is the submission of electronic Common Technical Documents (eCTD) to the regulatory authorities, such as FDA, MHRA and EMA.

In recent decades, we’ve seen a significant increase in the number of regulatory designation schemes launched by regulators to incentivise development in specific areas underserved by current therapies.

For many early-stage and start-up biotech companies, a key consideration is how to prepare to be investor ready, to raise the funding required to progress product development programs.

In this three-part blog series, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice and guidance for sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome.

In this three-part blog series, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice and guidance to sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome.

The field of clinical trials within the European Union (EU) has undergone a significant transformation in recent years driven by implementation of the new Clinical Trials Regulation (EU No 536/2014) (CTR) aimed at harmonisation of the rules across the EU for conducting clinical trials, enhancing patient safety, data transparency and overall trial efficiency.

In this three-part blog series, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice and guidance to sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome.