medical-writing
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Celegence Found the Unsexy AI Business: Fixing the Paperwork That Keeps Medicine on the Market
Two sisters started with regulatory services, watched their own writers wrestle with hundred-page reports, and built software around the bottlenecks. The result is a useful playbook for enterprise AI: begin with paid work, reject the clever features that cannot be checked, and automate only what experts can defend.
Ritivel
Ritivel is an AI-native workspace for regulatory and medical writing teams at life sciences companies. Its AI agents draft dense regulatory documents - CTDs, CSRs, INDs, and BLAs - directly in Microsoft Word, following FDA formatting rules and pulling from a company's own clinical data and prior submissions, with every claim cited back to its source. The goal is to compress work that normally takes weeks of manual synthesis into minutes, helping drugs reach patients sooner.
HiRO - Harvest Integrated Research Organization
HiRO (Harvest Integrated Research Organization) is a full-service, globally oriented clinical research organization founded in 2020 that helps biotech companies run clinical trials across borders. Positioning itself as an 'integrated' rather than a traditional 'contract' research organization, HiRO connects Asian biotechs seeking trials outside their region with US and European sponsors wanting to run studies in Asia. Backed by a tens-of-millions-of-dollars Series A led by OrbiMed and built out through three CRO acquisitions, it offers end-to-end services from preclinical strategy to regulatory submission, with deep expertise in oncology and rare disease.
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.