What Ritivel does
Ritivel is an AI-native platform that automates the drafting of regulatory submissions for life sciences companies. It generates documents such as Clinical Study Reports (CSRs), CTD modules, and related regulatory filings, using AI trained on medical and regulatory language rather than a generic model.
Key capabilities
The platform can convert protocols and study data into complete CSRs, auto-generate tables, listings, and figures from source data, and draft CTD Module 2 summaries with automatic cross-references. It provides regulatory search for answers grounded in FDA and ICH guidelines and maintains word-level traceability linking each statement back to its source document. Ritivel emphasizes local deployment within a company's own infrastructure, with no cloud storage or model training on user data.
Who it's for
Ritivel serves pharma, biotech, and medtech companies, along with CROs and CDMOs, that need faster, consistent, and auditable regulatory documentation for submissions and approvals.