Ritivel is an AI-native workspace for regulatory and medical writing teams at life sciences companies. Our AI agents draft CTDs, CSRs, INDs, and BLAs in minutes instead of weeks, helping drugs reach patients faster. Every month a drug is delayed from reaching the market costs pharma companies ~$45M in lost revenue and more importantly, delays treatment for thousands of patients who need it. Yet regulatory teams are stuck in a painful, months-long process: synthesizing thousands of pages of clinical data, hunting through SharePoint folders for the right documents, chasing colleagues for missing inputs, and manually drafting submissions. Ritivel deploys AI agents that transform how regulatory teams work. Our agents generate comprehensive first drafts directly in Microsoft Word, following FDA formatting requirements and pulling from your existing clinical data and prior submissions. Every data point includes citations linked back to the original source, so reviewers can verify with one click. Connected to SharePoint and Veeva, our agents automatically source the right documents. Integrated with Outlook, they handle reminder emails and follow-ups automatically. We're engineers who previously built AI copilots at Microsoft Research. After 50+ conversations with pharma professionals, we discovered the critical bottleneck in regulatory submissions and built Ritivel to solve it.
