The EU Clinical Trials Regulation (CTR 536/2014), in effect since January 2022, has significantly reshaped the clinical trial landscape across Europe.

This case study showcases Clinigen’s proactive and strategic approach to one of the most complex regulatory transitions in recent years - focusing specifically on packaging and labelling adaptations. 

Discover how we supported our client in achieving a seamless transition to CTR compliance – not just by responding to regulatory change, but also by empowering them through the process with clarity and flexibility.