Ritivel provides an AI‑native platform that automates the drafting, updating, and management of regulatory submission documents for pharma, biotech, medtech, CROs and CDMOs. The system delivers deterministic, domain‑specific text with word‑level traceability to source data, reducing review cycles, errors, and audit risk, while running entirely on‑premises to keep confidential data under the customer’s control.
Funding
Funding not disclosed
Founders
Product
Problem
Regulatory teams in pharma, biotech, medtech, and CROs spend months manually drafting, updating, and reviewing complex submission documents, leading to delays, inconsistencies, and high risk of errors or audit findings.
Solution
Ritivel offers an AI‑native platform that automates the creation and maintenance of regulatory submission documents while preserving the traceability, consistency, and domain‑specific accuracy required by regulators. The system generates draft text that is reproducible—identical inputs always produce identical outputs—reducing unexpected changes between review cycles. Every statement is linked at word‑level to its source data, enabling instant answers to auditor or reviewer queries. The platform is deployed locally within the customer’s infrastructure, ensuring that confidential data never leaves the organization’s control. By handling repetitive drafting tasks, Ritivel lets regulatory professionals focus on scientific work and accelerates the path to FDA approval.
Target Audience
Primary users are regulatory affairs teams at pharmaceutical companies, biotechnology firms, medical device manufacturers, CROs, and CDMOs that prepare FDA submissions and related documentation.
Features
- AI models trained on medical and regulatory language to produce accurate, domain‑specific content for CTDs, CSRs, INDs, and other high‑stakes filings
- Word‑level traceability linking each claim, number, and phrase back to its original source document
- Deterministic output generation guaranteeing consistent drafts across revisions and review cycles
- Fully on‑premises deployment with no cloud storage, meeting strict data‑privacy and compliance requirements
- Integrated workflow tools that automate drafting, versioning, and update propagation across large regulatory dossiers