Tehistark provides an AI‑driven AutoDossier platform that automates the creation of IND and other regulatory submission documents for biotech companies. By extracting and organizing experimental data, the system generates complete, compliance‑ready dossiers, cutting preparation time and reducing manual effort in the regulatory workflow.
Funding
Funding not disclosed
Founders
Product
Problem
Biotech companies face labor‑intensive, error‑prone processes when preparing Investigational New Drug (IND) applications and other regulatory dossiers, often requiring extensive manual data entry and expert review to meet diverse global standards. Delays and compliance gaps can extend development timelines and increase costs.
Solution
Tehistark’s AutoDossier platform applies machine‑learning models to extract, structure, and auto‑populate required dossier sections from source data, dramatically reducing manual effort. The system continuously validates content against up‑to‑date regulatory guidelines for major agencies, ensuring consistent compliance across regions. Users collaborate in a secure cloud workspace where changes are tracked and audit‑ready reports are generated automatically. Integration points allow direct import from laboratory information systems and export in eCTD‑compatible formats, streamlining the handoff to regulatory authorities. By accelerating dossier assembly and minimizing revision cycles, the platform shortens IND submission timelines and lowers operational costs for biotech firms.
Target Audience
Primary customers are biotechnology companies and contract research organizations that manage IND filings and other regulatory submissions, as well as internal regulatory affairs teams seeking to automate dossier preparation.
Features
- AI‑driven content extraction and auto‑population for all IND dossier modules
- Real‑time regulatory rule engine that checks compliance with FDA, EMA, PMDA, and other global agencies
- Secure, multi‑user collaboration with version control and immutable audit trails
- One‑click export to eCTD and other submission formats for seamless regulatory filing
- API connectors for laboratory information management systems (LIMS) and clinical data warehouses
- Dashboard analytics that track preparation progress, identify bottlenecks, and forecast submission dates