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.
Beyond Risk Flagging
Regulatory experts and AI — working together across your documents and process. We don't just flag what's wrong: we fix it. From risk identification to revised documents and submission-ready packages, we get you there faster and with less rework.
How We Work With You
A fully integrated process — from your first document to your final submission.
Step 1
We assess your full picture
Protocols, DHFs, CERs, labeling — analyzed together, across documents and your entire development process. Not one file at a time.
Step 2
Experts + AI identify what matters
Risks ranked by severity and priority — grounded in FDA, EMA, MDR, EFSA, EU Health Claims, Cosmetics Regulation 1223/2009, and HTA frameworks, and benchmarked against existing approvals in your space.
Step 3
We fix it and deliver
We don't hand you a report. We draft the revisions, update your documents, and hand back a submission-ready package — ready to file.
The Business Case
Teams using CogniLens reach submission faster, with less back-and-forth and fewer costly surprises.
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, HTA, EFSA Novel Food, EU Health Claims Regulation 1924/2006, and EU Cosmetics Regulation 1223/2009 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
- Food supplement companies (EFSA Novel Food notifications, Health Claims Regulation 1924/2006 substantiation)
- Cosmetics manufacturers (EU Cosmetics Regulation 1223/2009, CPNP notifications, product safety reports)