AIOS DNA Pharmaceutical Intelligence Suite
Dual-Mode Enterprise AI for the Entire Drug Lifecycle
Transform pharmaceutical operations from drug discovery through commercialization with an enterprise-grade dual-mode AI platform. Choose deterministic mode for regulatory compliance and auditable decisions, or LLM-enhanced mode for adaptive intelligence. Built on the AIOS DNA kernel mesh with enterprise-grade governance, security, and observability.
Industry Challenges
Pharmaceutical companies face unprecedented challenges:
Dual-Mode Architecture
Every pharmaceutical kernel operates in two modes, giving you the flexibility to choose the right approach for each use case:
Deterministic Mode
Rule-based, reproducible operations with no LLM calls. Perfect for regulatory submissions, audits, and compliance-critical workflows.
- •100% reproducible results
- •Full audit trails
- •FDA/EMA compliant
- •P95 latency < 500ms
LLM-Enhanced Mode
Adaptive reasoning using large language models for exploratory research, hypothesis generation, and complex analysis.
- •Adaptive intelligence
- •Novel insights
- •Contextual understanding
- •P95 latency < 2000ms
Solution Modules
Five specialized domain kernels with dual-mode operation that integrate seamlessly with the AIOS DNA platform:
Drug Discovery Kernel
Generative molecule design, toxicity prediction, binding affinity scoring, and multi-objective optimization across efficacy, safety, and manufacturability.
Clinical Trials Intelligence Kernel
AI-powered patient matching, protocol optimization, Risk-Based Monitoring (RBM), real-time data quality checks, and dropout prediction.
Regulatory Compliance & Safety Kernel
Automated FDA/EMA CTD module generation, Risk Management Plan (RMP) automation, pharmacovigilance anomaly detection, and submission package assembly.
Manufacturing & Supply Chain Kernel
Predictive Quality Control (PQC), batch deviation detection, equipment reliability forecasting, serialization, and cold-chain monitoring.
Commercial Intelligence Kernel
Market access modeling, demand forecasting, launch planning optimization, KOL network mapping, and competitive intelligence analysis.
Enterprise-Grade Governance
Built-in governance controls ensure compliance and auditability across all pharmaceutical operations:
Mode Enforcement
Enforce deterministic-only mode for GxP-critical operations while allowing LLM-enhanced mode for research.
Human Approval
Route high-risk operations through human approval workflows with full audit trails.
Explainability
Rule-based reasoning and decision trees for all deterministic operations with regulatory traceability.
Governance Features
- •Per-tenant mode configuration
- •Rule version pinning and management
- •Comprehensive audit trail generation
- •Real-time compliance monitoring
- •Automated compliance reporting
- •Data residency and sovereignty controls
Architecture
The Pharmaceutical Intelligence Suite integrates with the AIOS DNA dual-mode kernel mesh, providing:
- •Seamless integration with existing pharma systems (EHR, CTMS, eTMF, LIMS, MES, SCADA, ERP)
- •Federated memory with patient data isolation and cross-study reasoning
- •SentinelX security monitoring and audit logging for all AI decisions
- •Human-in-the-loop approval workflows for regulatory and safety-critical actions
Expected Impact
Additional Benefits
- •Reduced time to market for new drugs
- •Improved patient safety and outcomes
- •Enhanced regulatory compliance
- •Better manufacturing quality and efficiency
- •Optimized commercial strategy and launch
- •Full audit trails for regulatory inspections
Regulatory Compliance
Built with compliance at the core, supporting all major pharmaceutical regulations:
- •Electronic records and signatures compliance (21 CFR Part 11, Annex 11)
- •Patient data protection (HIPAA, GDPR)
- •Good Practice quality guidelines (GMP, GLP, GCP)
- •Audit trails for all AI-generated outputs and decisions
- •Data residency and sovereignty controls
- •Encryption at rest and in transit (TLS 1.2+, AES-256)
Transform Your Pharmaceutical Operations with Dual-Mode AI
See how AIOS DNA's dual-mode architecture can accelerate your drug development, optimize clinical trials, automate regulatory compliance, and drive commercial success. Choose deterministic mode for regulatory submissions or LLM-enhanced mode for research breakthroughs. Request a demo tailored to your pharmaceutical use case.