About This Expert

I partner with biotech and pharmaceutical organisations to deliver end‑to‑end CMC and Regulatory Affairs strategy across the full drug development lifecycle — from early‑phase research through clinical development and into commercialisation. My consultancy focuses on global regulatory strategy, with strong expertise in CMC regulatory support for biologics, ATMPs/CGTs and small‑molecule products, ensuring programmes are built on clear, phase‑appropriate and globally aligned foundations. I bring deep experience in the authoring, critical review and strategic positioning of Module 3, Module 2.3 (Quality Overall Summary) and IMPDs, ensuring that CMC narratives are scientifically robust, coherent and aligned with evolving MHRA, EMA and FDA expectations. My work strengthens submission readiness, supports confident agency engagement and accelerates progression through global clinical application pathways. Beyond documentation, I provide commercially informed global regulatory strategy — shaping development plans, defining regulatory roadmaps, assessing CMC readiness and ensuring alignment between scientific, operational and regulatory objectives. This includes CMC regulatory strategy, regulatory affairs planning and technical writing support tailored to complex modalities. With long‑standing experience across drug development, I combine scientific depth with a practical, commercially aware consultancy approach. My focus is to translate complex regulatory requirements into actionable, high‑impact solutions that move products efficiently from concept to clinic and ultimately to market.

Certifications