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
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
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
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

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Blogs

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