regulatory-submissions
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EDETEK and the art of making clinical data behave
A drug trial can collect mountains of evidence and still struggle to make it usable. EDETEK sells the software, standards, and specialist labor that help those mountains become a regulatory submission.
Instem and the surprisingly expensive life of a lab result
A discovery is only as useful as the evidence that travels with it. Instem has built a business around helping that evidence survive the journey from laboratory bench to regulatory review.
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.
Priya Paul
Priya Paul (Bhutani) is the founder and CEO of RegDesk, an AI-powered regulatory intelligence and management platform for medical device and pharmaceutical companies. A biomedical engineer turned regulatory strategist, she spent years watching life-changing devices stall in regulatory limbo - up to 80% of applications get rejected for reasons unrelated to safety - and built RegDesk in 2014 to compress submissions that once took months into days. She leads the company's product vision and global growth, and RegDesk is a certified Minority Business Enterprise.