This presentation introduces “QAI,” an AI-powered SaaS platform developed by a University of Tokyo–originated startup to support document-intensive workflows in the pharmaceutical and healthcare industries. Covering clinical development, regulatory affairs, quality assurance, manufacturing, marketing, and hospital operations, the session demonstrates how AI enables efficient document creation, review, search, training, and knowledge utilization through real-world use cases. It also discusses how large language models (LLMs) are transforming regulated industries and outlines future directions for AI adoption in pharmaceutical and healthcare domains.