AgileWriter is an AI-powered tool designed to streamline the creation, redaction, and formatting of both clinical and non-clinical documents required for regulatory submissions. Tailored specifically for medical writers, it automates time-consuming tasks such as document drafting, version tracking, compliance formatting, and sensitive data redaction. AgileWriter integrates seamlessly with existing workflows and supports collaboration with sponsors, reviewers, and publishing teams. By leveraging advanced natural language generation and domain-specific knowledge, it ensures speed, accuracy, and regulatory compliance—reducing manual workload while enhancing the quality and consistency of submission-ready documents.