Ritivel
AI-native regulatory platform for life sciences that automates clinical and regulatory documentation with 100% reproducibility and word-level traceability.
Where Ritivel ranks
Current edition · updated Oct 20, 2026About Ritivel
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.
Products
Automates CSR drafting from Protocol and Statistical Analysis Plan inputs, generating non-data sections, biostatistical Tables Listings and Figures, and data-centric sections wi...
Accelerates Common Technical Document submissions by automating Module 5 literature search across PubMed and web sources, and drafting Module 2 summaries with automatic cross-re...
Provides instant answers from FDA, EMA, and ICH guidelines for regulatory intelligence, plus an enterprise feature for searching internal documents, studies, and submissions.
Security and compliance
As reported by Ritivel. Ask for audit reports before you buy.
- 256-bit encryption for data at rest and in transit
- Zero data retention
- No model training on customer data
- 100% local deployment
- Air-gapped ready
- Audit logging
- Role-based access control
- IP allowlisting
- Word-level traceability
- Deterministic outputs
Is this your company?
Claim the profile to keep facts current, answer buyers and submit evidence for the next ranking review.
Claim Ritivel