TheonlyregulatoryAIwith100%reproducibility.

Draft CSRs, CTD modules, and search regulations—with complete traceability and zero cloud dependency.

Backed by
Y Combinator
Built by experts from
Microsoft

Built for regulatory teams at

Pharma
Biotech
CROs
CDMOs
Medical Devices

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

Protocol + SAP in, complete CSR out. Minutes, not weeks. Word-level traceability.

Non-data draftingAuto TLF generationData-centric sections

CTD Automation

Literature search via PubMed. Auto-draft Module 2 summaries with cross-references.

Module 5 LiteratureModule 2 DraftingAuto Cross-References

Regulatory Search

Instant answers from FDA and ICH guidelines.Try it now — no signup required
FDA • ICHEnterprise Search

Every document, for every stage of development

Extend automation across your entire regulatory workflow.

Clinical Study Reports (CSRs)
IND, NDA, BLA Modules
CTD Module 2 Summaries
CTD Module 5 Literature
Nonclinical Study Reports
Investigator Brochures (IBs)
Statistical Analysis Plans
Tables, Listings, Figures (TLF)
Protocols & SOPs
Briefing Documents
Safety Documentation
And more...

Why regulatory teams choose Ritivel

We built Ritivel from the ground up for the unique demands of life sciences.

Minutes, Not Weeks

What used to take weeks of manual drafting now happens in minutes. 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.

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Enterprise-grade security, by design

Your data never leaves your infrastructure. Built for the most demanding security requirements.

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100% Local Deployment

No data stored on cloud. Your data never leaves your infrastructure. Complete data sovereignty.

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No Model Training on Your Data

Your data is never used to train models. Zero data retention policy. Your IP stays yours.

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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 minutesseconds, not weeks—with complete traceability.