The sovereign AI-to-ASI stack purpose-built for bio-clinical enterprises. From idea to autonomous discovery — governed, certified, and profitable across the next 10 years.
Hard metrics. Contracted delivery. No ambiguity in what AI investment returns for your BIO enterprise.
Unified ingestion layer for genomic sequences, EHR data, imaging stacks, trial protocols, and regulatory filings. Real-time, zero-copy, sovereign.
Layer 1 · FoundationMulti-agent framework coordinating discovery, trial, regulatory and commercial agents. Self-healing workflows with human-oversight gates.
Layer 2 · Core · L5 ReadyCertified ML models for drug-target interaction, patient stratification, adverse event prediction, and clinical endpoint optimisation.
Layer 3 · GxP CertifiedSovereign large language model trained on FDA, EMA, PMDA, and 140+ global regulatory corpora. Submission drafting, gap analysis, audit-ready.
Layer 4 · Sovereign LLMSandboxed AGI reasoning module for multi-step hypothesis generation, cross-domain knowledge synthesis, and novel compound prediction.
Layer 5 · Sandboxed AGIIndustry 5.0-compliant enterprise resource platform for bio entities. Self-optimising, autonomy-native, with full GxP audit trail and HA/DR Level 5.
Layer 6 · Industry 5.0 ERPISO 42001-aligned AI Management System with real-time bias auditing, model explainability, sovereign kill-switch architecture, and continuous compliance monitoring across all stack layers.
Layer 7 · Governance · ISO 42001 · GxP · HITRUSTAI surfaces insights and recommendations. Humans make all decisions. Typical entry point for new BIO deployments.
AI executes defined workflows autonomously with human approval gates for material decisions. Co-pilot mode.
AI manages complex multi-step BIO workflows autonomously within defined parameters. Human oversight at boundaries.
AI-led discovery, trial planning, and regulatory engagement. Humans define goals; AI manages execution end-to-end.
Fully autonomous BIO intelligence. Self-optimising ERP. ASI-governed discovery with AAI Ethics Layer enforcement. Zero unplanned downtime.
Full AI Management System certified to ISO 42001. Real-time model monitoring, bias detection, and explainability modules. Audit-ready at all times.
All AI components validated under GxP principles. Full audit trail. 21 CFR Part 11-compliant electronic records and signatures. FDA submission-ready.
Regional data residency enforced by architecture, not policy. GDPR, HIPAA, and APAC-specific data sovereignty controls built into the stack foundation.
Sovereign kill-switch for all autonomous agents. Human oversight gates at defined autonomy thresholds. AAI Ethics Board review for ASI-phase actions.
Human-centric, resilient, and sustainable AI. Certified against Industry 5.0 criteria for bio-clinical settings — the only platform with this certification.
Self-healing, geo-distributed architecture. Zero RPO for life-critical BIO systems. 99.999% SLA with autonomous failover and recovery orchestration.
HITRUST CSF r2 certified. SOC 2 Type II attested annually. ISO 27001 information security management. NIST AI RMF aligned.
AI-native compliance monitoring that auto-updates regulatory frameworks as FDA, EMA, PMDA guidance evolves. No manual gap assessments required.