CogniLens Information

CogniLens — Predictive Regulatory and Market Access Intelligence for Drugs and Medical Devices Regulatory and design missteps cost the life sciences industry billions — delaying approvals and patient access. CogniLens helps biotechs, medtechs, CROs, and regulatory consultants see risks months before submission. What it does: CogniLens analyzes draft clinical, technical, and regulatory documents to identify potential regulatory, scientific, and design risks up to 10× faster than manual review — reducing redesigns, protocol amendments, and submission queries by 30–50%. How it works: Built on a proprietary regulatory knowledge graph and an explainable AI scoring engine, CogniLens transforms complex regulatory guidelines into actionable insights and decision trees. It provides clear explanations, linked guideline references, and targeted mitigation guidance — empowering faster, more compliant development. Proven performance: Trained on historical regulatory outcomes and documentation across drugs, devices, and combination products, CogniLens achieved precision 0.88 and recall 0.91 — demonstrating strong predictive alignment with real-world review results. Platform modules: • Protocol Lens – Predictive risk scoring for clinical trial protocols • Design Lens – Detect gaps in device design documentation • Submission Lens – Validate consistency across CTD modules and device dossiers • Labeling Lens – Align claims and justifications with regulatory precedents Data privacy & security by design: CogniLens can be deployed in your secure environment, with EU/US-compliant hosting options available. Learn more: www.cognilens.ai