AI Agents for drafting of regulatory documents
Your regulatory and quality teams move faster, without giving up control. Visium builds AI regulatroy document workflows designed for the humans who remain accountable for every submission.
CTD Modules & CSR · APQR · GVD · Human-in-the-Loop by Design
From source data to submission-ready draft — six engineered steps
Start with trusted templates
Upload your company templates, choose from our curated template library or create a new template.
Seamlessly integrate your data
Connect internal and external source data for a foundation.
Let our team of AI Agents generate high-quality drafts
Easily define how your agents operate, from triggering logic to task orchestration. Do all of it within a secure, no-code environment.
Edit the draft with the help of your experts and our AI Agents
Refine documents directly or via prompting our AI Agents and delegate review tasks to your human experts.
Enhance quality and compliance
Review Agents check the full document for consistency & compliance.
Accelerate answers to authority questions
If you get question or audit request from regulators, our AI Agents can instantly draft answers.
Measured impact
<10 min
For first draft
Higher quality, consistency and compliance.
30–70%
Reduction in authoring time
Faster, smoother health authority review cycles.
2-7 weeks
Reduction in lead time
Teams freed to focus on the work that matters most.
Built around your workflows
Most document automation tools require you to adapt to their structure. Visium is configured to yours; your templates, your data systems, your institutional knowledge, your review processes.
Configured to your environment, not a generic standard
Upload your regulatory templates, and document standards
Connect your existing data systems.
The Document Factory operates against your specific requirements from day one.
Reusable architecture across document types
Once the core workflow is configured, adding a new document type does not require starting from scratch.
Shared components: source connectors, review logic, audit architecture, are reused and extended.
Your investment compounds rather than resets with each new use case.
Structured collaboration between experts and AI — with humans in control
After the first AI-generated draft, the system routes work to the right expert at the right stage
Regulatory writers, medical reviewers, quality leads, and data owners each interact within their defined scope
Deployed in your secure environment
The platform runs within your cloud infrastructure or a dedicated private tenant.
No data crosses into shared environments.
Meets ISO 27001 and SOC 2 Type II requirements, with deployment options designed to satisfy internal IT governance and data residency requirements.
The controls your compliance and IT teams will ask about — already built in
Every agent action is logged, traceable, and exportable for regulatory inspection; with role-based controls, GxP validation support, and human sign-off built into the workflow before deployment, not bolted on afterward.
ISO/IEC 27001-aligned ISMS (certification planned for 2026) and SOC 2 attestation planned.
Privacy-by-design aligned with GDPR and HIPAA-ready architecture.
Validation-ready architecture supporting GxP-regulated workflows (e.g. audit trails, reliability, HIL)
Risk-based AI safety framework aligned with FDA/EMA guidance and EU AI Act principles.
We connect what matters: Any system, every stack
