Submit with Speed. Respond with Confidence.
From INDs and NDAs to global variations, author, compile, submit, and manage regulatory documents faster - powered by domain-trained AI copilots and audit-ready workflows
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What Our Customers Gain
40% faster eCTD document assembly
60% fewer submission errors with built-in validation
Real-time global submission tracking
AI-assisted authoring and content reuse
Faster response to agency queries across regions
Regulatory Submissions – End-to-End Intelligence for Global Compliance
Regulatory teams today are expected to move faster without compromising compliance. Our Regulatory Submissions Agent streamlines authoring, timelines, and global coordination, enabling teams to submit faster and respond smarter with domain-trained Agentic AI copilots
Regulatory Submissions
AI-Assisted Authoring
Generate CTD modules using domain-aware copilots trained on past submissions, with content reuse blocks, source mapping, and traceable version control
Submission Planning & Timeline Management
Coordinate internal and affiliate submissions using intelligent planning boards, dependency tracking, and SLA alerts for submission milestones
Automated Compilation, Publishing & Submission
Simplify document compilation for FDA, EMA, PMDA, and more with built-in validation rules, format conformance checks, and eCTD publishing workflows
Real-Time Status Monitoring & Agency Response
Monitor submission status across markets. Automatically detect agency queries and generate first-draft responses using trained templates and historical response patterns
Why Choose Agilisium
Purpose-Built for Global Regulatory Submissions
eCTD-ready, validated agents that streamline IND, NDA, BLA, and variation submissions globally
Agentic AI That Acts, Not Just Advises
Draft, validate, and respond, copilots trained on real regulatory content and workflows
Trusted by Global Regulatory Teams
Proven time and cost savings, improved submission accuracy, and better coordination across affiliates and regions
Let’s Redefine Regulatory Submission Excellence
Faster authoring. Fewer errors. Greater global visibility
Who We Serve
On the journey from Molecule to Medicine, we fast-track innovation across the pharma value chain
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