Context AI/
Regulatory Intelligence
Regulatory Intelligence Agent
Accelerates submission readiness, regulatory document authoring, and compliance monitoring.
50%
Faster Submission Prep
70%
Less Manual Document Review
40%
Reduction in Compliance Gaps
3x
Faster Regulatory Updates
What We Do
Streamlining regulatory operations for faster approvals and sustained compliance.
1. Commercial AI
1. Commercial AI
1. Commercial AI
Sales operations agent
Market access agent
Marketing Intelligence Agent
Market Affairs agent
Problem Addressed
Regulatory submissions are document-intensive and time-sensitive, with evolving global requirements creating compliance complexity and approval delays.
Value Chain Fit
Supports regulatory affairs throughout the product lifecycle, from IND preparation through post-market compliance, ensuring submissions are complete, consistent, and timely.
Key Capabilities
Core Features & Functions
Purpose-built AI capabilities designed for your specific workflows and challenges.
1. Commercial AI
1. Commercial AI
1. Commercial AI
Sales operations agent
Market access agent
Marketing Intelligence Agent
Market Affairs agent
Document Authoring
AI-assisted drafting of regulatory documents with automated content generation, consistency checks, and template compliance.
Submission Planning
Intelligent milestone tracking and dependency management for complex regulatory submissions across global markets.
Compliance Tracking
Continuous monitoring of regulatory compliance with automated gap analysis and remediation tracking.
Regulatory Updates
Real-time monitoring of regulatory changes worldwide with impact assessment and notification workflows.
Key Capabilities
Your Competitive Edge
Technology that helps you win more bids and deliver exceptional results
Accelerate IND/NDA/BLA document preparation by 50%
Automate regulatory intelligence gathering and analysis
Automate regulatory intelligence gathering and analysis
Monitor global regulatory changes and assess impacts
Ensure document consistency across submissions
Generate compliance gap analysis reports automatically
How Clients Engage
From Assessment to Scale
Our proven engagement model ensures successful deployment and lasting value.
1. Commercial AI
1. Commercial AI
1. Commercial AI
Sales operations agent
Market access agent
Marketing Intelligence Agent
Market Affairs agent
Assess
We evaluate your current state, identify opportunities, and define success metrics.
1
Design
Collaborate on solution architecture tailored to your workflows and data landscape.
2
Implement
Deploy the agent with integration support, training, and change management.
3
Scale
Expand capabilities across use cases, teams, and geographies with continuous optimization.
4
Our Solutions
We accelerate the delivery of therapies to patients through Gen AI enhanced industry solutions
Gene Inspector
REVOLUTIONIZE YOUR OMICS EXPERIMENTS WITH AI
Transform how researchers approach Omics experiments with accelerated biomarker discovery.

Biomarker Chatbot
UNLOCKING PRECISION MEDICINE WITH GEN AI
Streamline the discovery, analysis, and application of biomarkers in clinical research.

Gen Insights
Gen AI Powered Self Service Analytics Platform
Get relevant data insights faster and easier with our AI-driven decision intelligence platform.

Blogs
Insights & Resources
Similar Case Studies
Recent White Papers
Transform Your Clinical Operations
Partner with us to deliver faster, higher-quality clinical trials with technology that scales.




































.jpg)
.jpg)
.webp)

.webp)





.avif)
.avif)
