Toxicology Strategy in Drug & Device Development: From ICH S Guidelines to Regulatory Dossiers
For regulatory experts, toxicology is more than scientific requirements− it is a strategic decision that can create a future product. From dealing with conventional drugs, complex biologics, small molecules, and other novel combinations, the approach to toxicology testing can determine regulatory outcomes and market performance. Here, we investigate how organizations can build strong toxicology strategies, follow ICH S guidelines, and prepare regulatory dossiers that balance compliance with clinical planning.