Meet Helio: Your Regulatory Co-Pilot for eCTD
Agentic automation for faster, traceable, regulator‑ready dossiers.
Multi-Region Consistency at Scale
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What you can do with Helio
Helio automates the hardest parts of regulatory authoring so you can move from idea to eCTD submission with confidence.
Structured Authoring
Start from prebuilt CTD kits, upload existing content, or auto‑generate drafts. Every line is source‑linked for traceability.
Lifecycle Management
See which sections live where across all dossiers. Track status and changes across the document lifecycle.
Validation & Review
ICH checks, cross‑module consistency, and reviewer workflows with grammar, coherence, and formatting aids.
Submission & QA
Track completeness, assemble eCTD, upload directly, and prepare regulator Q&A with evidence retrieval.
Why Teams Trust Helio
Security
Deployed securely in your environment. Enterprise‑grade compliance with audit trails, encryption, and access controls.
Expandability
Built on SyncIQ’s Agentic OS, Helio expands across regions, regulatory authorities, and drug types — while also connecting with future SyncAgents (QA/GMP, SOP, MSL, Research).
Integrations
Works with your RA ecosystem: Veeva, SharePoint, Teams, ESG, Documentum, and more.
Helio is Powered by SyncIQ
Multi-Agent System
Coordinated AI agents handle authoring, validation, cross-module checks, Q&A, and submission tasks. This coordination reduces rework and improves quality across the dossier lifecycle.
Enterprise Grade
Built for regulated environments with the governance and scalability enterprises expect, so IT stays confident while regulatory teams move faster.
Blazingly Fast
Go from kickoff to measurable impact in weeks, not months. With prebuilt RA workflows and rapid knowledge ingestion we compress time-to-value to under five weeks.
Traceable with Human Intervention
Every action is reviewable, cited, and editable. Human-in-the-loop workflows and source-grounded outputs create an audit-ready trail regulators can trust.
Ready to Transform Your Submissions?
See how Helio turns bottlenecks into breakthrough for Regulatory Affairs teams.