Regulatory Submission

Streamlined regulatory submissions with AI-assisted authoring and comprehensive document management.

Key Capabilities

40%
Faster document authoring
60%
Reduction in review cycles
90%
First-cycle approval rate
3mo
Earlier market access

What We Do

1. Commercial AI
1. Commercial AI
1. Commercial AI
Problem Addressed
Regulatory submissions are complex, time-consuming, and error-prone. Organizations face pressure to accelerate submissions while maintaining quality and compliance across multiple global agencies.
Where It Fits
Critical endpoint of Clinical Development, translating clinical evidence into approved therapies through efficient regulatory submission and agency interactions.

Key Capabilities

1. Commercial AI
1. Commercial AI
1. Commercial AI
AI-Assisted Authoring
Generative AI tools accelerating document drafting with regulatory-compliant templates and content reuse.
Submission Planning
Complete electronic common technical document lifecycle management with publishing capabilities.
eCTD Management
Complete electronic common technical document lifecycle management with publishing capabilities.
Regulatory Intelligence
Real-time monitoring of regulatory changes and agency guidance across global markets.
Health Authority Tracker
Centralized tracking of all agency interactions, commitments, and responses.
Quality Review Automation
AI-powered quality checks ensuring submission completeness and compliance.

How Clients Engage

1. Commercial AI
1. Commercial AI
1. Commercial AI
Assess
Evaluate current state and identify opportunities
1
Design
Architect solutions tailored to your needs
2
Implement
Execute with proven methodologies and best practices
3
Scale
Optimize and expand for enterprise-wide impact
4

Our Solutions

We accelerate the delivery of therapies to patients through Gen AI enhanced industry solutions

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