Regulatory and market access intelligence for drugs and medical devices

See your product the way regulators will — months before submission. CogniLens applies AI and deep learning to flag risks 10× faster, explain why they matter, and suggest how to mitigate them. Reduce redesigns, avoid costly amendments, and accelerate approvals with predictive, explainable insights.

Request Demo
CogniLens AI Lens Graphic

The Problem

Regulatory setbacks cost teams millions — and delay patient access.

  • 80–90% of drug candidates and device projects face regulatory delays
  • Over 50% require redesigns or protocol amendments
  • €0.5M–1M+ in avoidable cost per amendment or redesign
  • Unseen documentation gaps derail submissions and trigger endless RA cycles

Development teams shouldn’t be blindsided. CogniLens helps you anticipate what regulators will question — before they do.

Our Platform

Predictive Regulatory & Market Access Intelligence for Drugs, Devices & Combination Products. CogniLens analyzes your protocols, design files, submissions, labeling, and clinical/technical documentation to identify risks early, explain why they matter, and suggest precise mitigation strategies.

How It Works

Upload

Submit protocols, DHFs, SAPs, labeling, CERs, or submission sections.

Extract

CogniLens automatically parses endpoints, comparators, specifications, claims, testing rationales, and more.

Assess

Flags technical, scientific, and regulatory risks (Low / Medium / High) — with linked regulatory guidelines and explainable decision trees.

Action

Get targeted recommendations to resolve issues before they become delays.

Impact

Fewer redesigns. Fewer protocol amendments. Faster approvals. Lower cost.

30–50% reduction in protocol amendments
Strong alignment with historical regulatory outcomes
0.88 / 0.91 Precision / Recall
10× faster development and smoother HTA pathways

Case: Illustrative Validation

CogniLens has been evaluated against historical regulatory outcomes across drugs, devices, and combination products. It consistently identified design and regulatory issues — from comparator selection to labeling justifications — that were later cited as amendment or refusal drivers. With a precision of 0.88 and recall of 0.91, CogniLens demonstrates strong predictive alignment with regulatory outcomes, helping teams anticipate risks early, reduce costly rework, and accelerate development.

Priority: Critical

Risks detected. High probability of refusal. Drives additional regulatory questions and review time.

  • §8.5 Immunogenicity: MISSING No validated ADA assay description found in Module 5.3.1.4. (Violates ICH S6).
  • §10 Statistical Plan: NON-COMPLIANT Sample size (N=40) listed without power calculation.
  • §5.2.3 Starting Dose: WEAK Rationale relies on "Previous Experience" rather than MABEL (Minimum Anticipated Biological Effect Level).

Trust & Security

Data Protection

Data is processed in a secure, data-privacy-aware environment under NDA/DPA. EU & US hosting options, including on-prem or private-cloud deployment. All data is minimized, pseudonymized, strongly de-identified, and never used for model training.

Expert Validation

Developed with an advisory board of regulatory and HTA experts.

Regulatory Grounding

CogniLens operationalizes FDA, EMA, ICH, MDR, PMA, 510(k), IEC, ISO, and HTA frameworks into explainable decision trees.

Who It’s For

Designed for teams navigating complex regulatory landscapes.

  • Drug developers (early- and late-stage)
  • Medical device companies (Class II/III)
  • Combination product teams
  • RA, Clinical, Quality, Systems, HF, and Market Access Teams
  • CROs and RA consultancies

See Risks Before Regulators Do

Stop guessing. Start predicting.
Give your team the advantage of AI-driven regulatory intelligence.