Submit with Speed. Respond with Confidence.
From INDs and NDAs to global variations, streamline every step, authoring, compiling, submitting, and tracking regulatory documents with traceable precision
Built for Every Stage of Submission
AI copilots assist in drafting CTD modules with content reuse
Submission planners track timelines, task status, and dependencies
Integrated workflows for compiling, publishing, and submitting to FDA, EMA, and global authorities
Never Miss a Regulatory Beat
Auto
detect and respond to agency queries with pre-trained response templates
Maintain
real-time status dashboards across global affiliates
60%
Built-in validation checks reduce submission errors
Who We Serve
On the journey from Molecule to Medicine, we fast-track innovation across the pharma value chain
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Discover more on how Agentic AI is scaling regulatory affair
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Gain a Competitive Edge
with AI-powered Content Generation
Streamline life sciences content development with
Agentic AI delivering compliance-ready, tailored outputs
at scale.