Problem · 01
Clinical-trial cryptographic provenance
Signed-data chains for clinical-trial integrity that survive a GxP audit without three months of manual evidence assembly.
IndustriesGxP · NIS2
Pharmaceuticals
Clinical-trial integrity. Regulatory-evidence chain for AI-assisted submissions.
Why this industry, why now
Pharma operates GxP-controlled clinical-trial pipelines and increasingly relies on AI for regulatory submissions. Quanterios produces the cryptographic provenance evidence GxP auditors expect and the AIBOM evidence FDA/EMA submission reviewers will start asking for.
What sits on your desk
Four problems specific to pharma.
Problem · 02
AI-assisted regulatory submissions
AIBOM evidence for the agents and models contributing to FDA/EMA submission packages.
Problem · 03
NIS2 cryptographic posture
DACH-pharma cryptographic estate evidence for NIS2 Annex II, tied to the BSI guidance.
Problem · 04
Long-retention research data
Decades-long research data sensitivity windows mean post-quantum exposure is already live.
What Quanterios brings
Four capabilities, mapped to what you actually need.
Capability · 01
CBOM Discovery
Cryptographic provenance across clinical-trial pipelines, lab systems, and submission packages.
Capability · 02
AIBOM Discovery
Inventory the AI agents and models contributing to regulatory submission decisions.
Capability · 03
PQC Migration
Hybrid rollout on long-retention research-data systems.
Capability · 04
Compliance & Evidence
GxP, NIS2 Annex II, and EU AI Act evidence in one refresh cycle.
Outcome
Pharma research organisations run Quanterios across both estates to produce GxP-aligned cryptographic provenance and AIBOM evidence for AI-assisted submissions.
Built for pharma.
Start with a free assessment for your estate.