RiskCortex Agentic AI

Agentic AI Automation for Regulatory Compliance

Enables autonomous orchestration of data retrieval, report generation, and compliance validation to streamline regulatory document creation with high accuracy and reduced manual effort.

Contextual Intelligence in Life Sciences

Agentic AI integrates diverse clinical, non-clinical, and manufacturing data sources to provide context-aware insights, improving decision-making in regulatory submissions and risk assessments.

Responsible and Ethical AI Deployment

Emphasizes transparency, bias mitigation, and explainability in AI-driven compliance processes to maintain trust and meet ethical standards, especially under evolving regulations like the EU AI Act.

Compliance with EU AI Act Requirements

Agentic AI solutions are designed to meet the EU AI Act's high-risk AI system obligations, including conformity assessments, human oversight, risk management, and technical documentation, ensuring legal compliance in the EU market.

LLM Policy and Governance

Incorporates large language model (LLM) policies to govern AI behavior, data minimization, and purpose limitation, preventing function creep and ensuring AI outputs align with regulatory and organizational standards.

Dynamic Workflow Orchestration

Automates regulatory alert creation and task prioritization across teams, enhancing operational efficiency and enabling regulatory affairs professionals to focus on strategic compliance and risk mitigation.

Proactive Risk Management and Auditability

Provides continuous monitoring, real-time compliance checks, and audit trails to identify regulatory risks early and support rigorous verification of AI-driven decisions.

Human-in-the-Loop Oversight

Maintains essential human control over autonomous AI agents to ensure meaningful review of automated decisions, particularly in high-impact regulatory contexts, aligning with GDPR and AI Act provisions.