NEWFeatured on Launch YC

Draft most accurate
regulatory submissions
in minutes, not weeks.

For Pharma, Biotech, Medtech, and CROs
to get faster FDA approvals

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

Faster Submissions, Fewer Review cycles, and Higher Confidence in every filing

Consistency

No surprises in reviews

Predictable outputs. No last-minute rewrites.

Regulatory reviewers expect consistency across drafts, updates, and submissions. Ritivel ensures the same input always produces the same output—so your documents don't change unexpectedly between reviews or resubmissions.

Why it matters: Fewer review cycles, fewer internal escalations, and lower audit risk.

Traceability

Always know where every statement came from

Defensible answers—instantly.

Every word, number, and claim can be traced back to its source document at word-level granularity.

Why it matters: When QA, auditors, or regulators ask 'Where did this come from?', you can answer immediately—without manual digging or guesswork.

Accuracy

Fewer errors in high-stakes documents

Built for medical and regulatory language—not generic AI.

Ritivel understands domain-specific terminology and maintains narrative consistency across sections and versions.

Why it matters: Fewer factual errors, fewer reviewer comments, and higher confidence submitting critical documents like CTDs, CSRs, and INDs.

Security

Your data never leaves your control

Designed for compliance-first environments.

No cloud storage. Fully local deployment. Your documents stay inside your infrastructure.

Why it matters: Meet internal IT, legal, and data-privacy requirements without exceptions or workarounds.

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

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.