regulatory-automation
(2)
Weave Bio
Weave Bio is a San Francisco-based, AI-native software company that automates the regulatory paperwork behind drug development. Its platform ingests preclinical and clinical study data and drafts submission-ready documents - INDs, investigator's brochures, clinical study reports and health-authority responses - in eCTD-ready format, cutting timelines that once took months down to hours while keeping human reviewers in the loop. Founded in 2022, Weave serves biotech, pharma, CROs and regulatory consultants, and raised a $20M Series A in October 2025 to bring total funding to roughly $36M.
RegDesk
RegDesk is an AI-powered regulatory information management platform for medical device, IVD, and pharma companies. It gives regulatory teams 24/7 access to up-to-date requirements across 120+ markets, automates submission-ready applications (GSPR checklists, Essential Principles, Declaration of Conformity), tracks changing regulations with daily alerts, and coordinates distributors - compressing submission work that once took three to six months into roughly a week.