CogniLens provides a predictive regulatory intelligence platform that analyzes technical and clinical documentation for drugs, devices, and combination products. The system automatically extracts key data points to assess scientific and regulatory risks against established guidelines. This proactive risk identification delivers targeted mitigation strategies, reducing protocol amendments and accelerating market access pathways.
Funding
Funding not disclosed
Founders
Product
Problem
Regulatory reviews frequently uncover undocumented gaps or non‑compliant elements in protocols, design files, and submission dossiers, leading to costly redesigns, protocol amendments, and delayed market entry for drug, device, and combination product programs.
Solution
CogniLens offers a predictive regulatory intelligence platform that ingests technical and submission documentation, automatically extracts relevant data points, and evaluates them against global regulatory frameworks such as FDA, EMA, ICH, MDR, and HTA guidelines. The system flags scientific, technical, and regulatory risks with a low‑, medium‑, or high‑severity rating and links each flag to the underlying guideline and an explainable decision tree. Users receive precise, actionable mitigation recommendations that can be incorporated before the next regulatory interaction, reducing the likelihood of amendment requests and accelerating approval timelines. The platform operates in a secure, privacy‑aware environment with options for on‑premises, private‑cloud, or EU/US hosting, ensuring that proprietary data remain confidential and are never used to retrain the model. By aligning predicted risk profiles with historical regulatory outcomes (precision 0.88, recall 0.91), CogniLens helps development teams streamline compliance and improve market‑access forecasts.
Target Audience
The primary users are drug development teams, medical‑device manufacturers (Class II/III), combination‑product groups, and associated regulatory affairs, clinical, quality, health‑technology assessment, and market‑access functions, as well as CROs and regulatory‑consultancy firms.
Features
- Document ingestion engine that accepts protocols, design history files, statistical analysis plans, labeling, clinical evaluation reports, and submission sections.
- Automated parsing of endpoints, comparators, specifications, claims, and testing rationales using natural‑language processing.
- Risk‑assessment module that maps extracted items to FDA, EMA, ICH, MDR, PMA, 510(k), IEC, ISO, and HTA criteria, producing severity scores and linked regulatory citations.
- Explainable decision‑tree visualizations that show why each risk was identified and how it aligns with specific guideline clauses.
- Targeted mitigation guidance with step‑by‑step recommendations to resolve identified gaps before regulator review.
- Secure data handling with pseudonymization, de‑identification, and optional on‑premise or private‑cloud deployment to meet GDPR and HIPAA requirements.
- Integration‑ready API and export formats for incorporation into existing quality‑management or clinical‑development workflows.
- Validation against historical regulatory outcomes demonstrating 30‑50 % reduction in protocol amendments and 10× faster development cycle assessments.