Weave

Weave Bio is an AI-native regulatory platform company that transforms how pharmaceutical and biotech teams prepare and manage complex regulatory dossiers across the therapeutic development lifecycle. The platform provides eCTD-formatted templates and accelerates data organization, authoring, review, publishing, and response management for fast, accurate, and confident regulatory submissions. Weave's expert-led AI approach shifts users from doing to directing, enabling teams to generate entire documents or sections, complex tables and summaries, and figures from uploaded source files at hyper-speed. The platform supports real-time collaboration with commenting, course-correction, and verification, allowing users to trace any content back to its source in two clicks, verify data, flag corrections, restore versions, track changes, and resolve comments. When new data points arrive, users can update layers of content with a few clicks, regenerating content and refining drafts with AI. Weave's product suite includes the core Platform, Submission Builder, and HAQ Manager, supporting every lifecycle stage and modality. The platform serves biotech companies with cost-effective, easy implementation and rapid ROI; pharmaceutical companies with enterprise scalability, advanced integrations, and compliance controls; and CROs and consultants with multi-client management and customizable branding. Two former FDA leaders have joined Weave's Strategic Advisory Board. Founded in 2022 and headquartered in New Haven, Connecticut, Weave Bio has raised $36.0M in Series A funding from investors including Innovation Endeavors, Magnetic Ventures, USVP, Character, and TMV.