TheonlyregulatoryAIwith100%reproducibility.
Draft CSRs, CTD modules, and search regulations—with complete traceability and zero cloud dependency.
Built for regulatory teams at
Achieving trust through better technology
Built for regulated industries where accuracy, traceability, and security are non-negotiable.
Consistency
100% reproducible outputs. Same input = same output, every time. Critical for regulatory compliance.
Traceability
Every word, number, and sentence traceable to source documents. Word-level granularity.
Accuracy
Domain-trained LLM with deep understanding of medical terminology. Consistent narrative across generations.
Security
No cloud storage. 100% local deployment. Your data never leaves your infrastructure.
Focus on science—not paperwork
Automate your most critical regulatory workflows with AI you can trust.
Clinical Study Reports
From Protocol + SAP to complete CSR in three steps:
- 1Instant non-data section drafting from Protocol + SAP
- 2Automatic biostatistical analysis → TLF generation
- 3TLF converted to data-centric CSR sections
CTD Automation
Accelerate your CTD submissions with intelligent automation:
- 1Module 5 Literature Search: Search PubMed and web sources for ANDA-relevant literature
- 2Module 2 Drafting: Ingest thousands of pages, generate summaries with automatic cross-references
Regulatory Search
Search and interpret the latest regulations specific to your drug or medical device. Instant answers, always up-to-date.
- 1Public regulatory intelligence search
- 2Enterprise: Search your entire internal data
Every document, for every stage of development
Extend automation across your entire regulatory workflow.
Why regulatory teams choose Ritivel
We built Ritivel from the ground up for the unique demands of life sciences.
Seconds, Not Weeks
What used to take weeks of manual drafting now happens in seconds. Free your team to focus on science, not paperwork.
Word-Level Traceability
Every word, number, and sentence can be traced back to source documents. Built for regulatory scrutiny from day one.
Domain-Trained AI
Our LLM is specifically trained on life sciences and regulatory content. It understands medical terminology and maintains consistent narrative.
Your Data Stays Yours
100% local deployment means your sensitive data never leaves your infrastructure. No cloud. No third-party access. Ever.
Enterprise-grade security, by design
Your data never leaves your infrastructure. Built for the most demanding security requirements.
100% Local Deployment
No data stored on cloud. Your data never leaves your infrastructure. Complete data sovereignty.
No Model Training on Your Data
Your data is never used to train models. Zero data retention policy. Your IP stays yours.
Air-Gapped Ready
Deploy in fully isolated environments. No external network dependencies required.
Ready to accelerate your regulatory submissions?
See how Ritivel can help your team draft CSRs in seconds, not weeks—with complete traceability.