Frédérique Vieville

Frédérique Vieville is a Regulatory Science expert and founder of 5QBD-Biotech. Over the past 25 years, she has combined strategic direction with hands-on leadership across development, manufacturing, quality, and regulatory functions for innovative biological products.
She developed strong expertise in bacteriophage therapy by leading CMC, Quality, and Regulatory activities from R&D through Phase II across Europe and the United States at PHERECYDES Pharma and PHAXIAM Therapeutics (2020–2024). She led GMP manufacturing transfers, analytical validation and specification setting, as well as regulatory interactions including Scientific Advice and clinical trial submissions in the EU and US, IVD CE marking (Directive 98/79/EC), and compassionate use programs supporting patient access.
She is co-founder and strategic lead of Phage-ACT (BEAM Alliance), contributing to European regulatory discussions shaping the framework for phage therapy in the fight against antimicrobial resistance. She holds a PharmD and an engineering degree in biotechnology.