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Ritivel

We turn clinical trial data into FDA submission documents in minutes

Ritivel turns raw clinical trial data into FDA submission documents in minutes. Traditionally, medical writers spend 8-12 weeks manually compiling data; our system uses study protocol and statistical outputs to instantly generate these reports with full traceability to the source data. Clinical development is pharma's biggest bottleneck. Despite rising R&D, trial timelines have increased 33% over the last decade. Accelerating clinical timelines by 20% unlocks hundreds of millions in additional revenue per drug by extending patent life. Generic AI fails in pharma due to a lack of traceability, with only 28% of pilots reaching production - the FDA requires traceability for all claims. Our proprietary engine solves this with word-level traceability, linking every generated sentence to clinical evidence. We deploy 100% on-premise to keep sensitive patient data within the client's infrastructure, making us a trusted AI partner for pharma. We automate the most complex parts of CSRs (clinical narratives and biostatistical analysis). Our high-quality output, validated by senior regulatory writers, costs 1/100th of human writing. We're built by experts from Microsoft, Kearney, and IQVIA - combining deep AI engineering with regulatory expertise to solve the "last mile" of drug development—a problem generic AI wrappers can't solve because they don't understand the standards or FDA requirements.
Active Founders
Nirmit Arora
Nirmit Arora
Founder
Co-founder and CTO @ Ritivel. Prev @ Microsoft Research focused on making agentic systems safe.
Gunin Gupta
Gunin Gupta
Founder
Cofounder and CBO @ Ritivel. Prev. @ AT Kearney focused on sustainability and energy process industries. Graduated with a bachelor's from IIT Bombay.
Pavan Kalyan (a.k.a PK) Tankala
Pavan Kalyan (a.k.a PK) Tankala
Founder
Cofounder and CEO @ Ritivel. Prev. @ Microsoft Research focused on training language models. Graduated from IIT Bombay with Btech + Mtech in Electrical+AI. Published @ Neurips, ACL, Interspeech.
YC Photos
Ritivel
Founded:2025
Batch:Winter 2026
Team Size:3
Status:
Active
Location:San Francisco
Primary Partner:Gustaf Alstromer