• Status Of AI Regulation On Drug Development

    As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more
  • An interview with Franco Negron

    In this interview, we spoke with Franco Negron, CEO of Simtra, about how the company is advancing its position as a premier CDMO for sterile injectables while preparing for the next wave of complex biologics. read more
  • An Interview With Franco Negron

    Simtra’s capability to support high-volume injectables and lower-volume modalities provides balanced expertise across the sterile injectables landscape. read more
  • Five Steps to Smooth Agentic AI Adoption

    In agentic AI-enabled labs, AI goes from individual, one-off applications to comprehensive workflow orchestration. read more