Elisabeth Ricchi

Are you looking to develop cutting-edge AI solutions to automate, optimize, streamline you Module 3 (Quality / CMC) authoring process while ensuring consistency in Module 3 documentation, reducing time-to-market and improving accuracy of your Module 3 ? I can help you. I have an extensive experience in pharmaceutical regulatory writing that supposes: 1) a perfect knowledge of regulations including ICH, EMA, and FDA guidelines, a perfect knowledge of Health Autority expectations 2) but also an ability to interpret and synthesize complex reports from development, CQ, manufacturing, etc... teams, turning scientific and technical details into clear, compelling, compliant regulatory narratives. I can help you train your IA model to identify regulatory-critical information from scientific/technical reports and turn it into structured CTD-compliant content.