RegIntel is VelorQ's domain-trained AI agent for pharmaceutical regulatory affairs. It ingests CDSCO, FDA, and EMA guidelines, assembles CTD/eCTD dossiers, tracks submission deadlines, and alerts you to regulatory changes — in real time.
From dossier ingestion to real-time alert monitoring, RegIntel handles the full regulatory affairs lifecycle so your team stays ahead of every deadline.
FDA 21 CFR, EMA guidelines, CDSCO Schedule Y — all three major pharmaceutical regulatory frameworks in one agent. No switching tools, no translation overhead.
Automatically structures CTD modules from your source documents. Generates eCTD-compliant XML and PDF packages ready for submission — gaps flagged before you submit.
Monitors agency feeds daily. Flags changes relevant to your active INDs, NDAs, or MAAs within 24 hours of publication — so you react first, not last.
RegIntel operates as a continuous intelligence layer — not a one-time tool — keeping your regulatory posture current across the entire drug lifecycle.
Upload your compound dossier, existing submissions, and relevant agency guidelines. RegIntel parses and indexes all document types including PDF, eCTD XML, and Word.
RegIntel cross-references your data against current regulatory requirements for each target agency, identifying gaps, inconsistencies, and non-compliant sections.
AI generates CTD/eCTD modules, identifies missing documents, and flags sections requiring human review before submission. Export-ready packages produced automatically.
Continuous monitoring of agency feeds; alerts sent when relevant guidance changes. Submission deadlines tracked and escalated with configurable lead times.
Whether submitting a first-in-class NDA or filing a generic ANDA across multiple markets, RegIntel adapts to your specific regulatory scenario.
Complete NDA package assembly for FDA submission. RegIntel structures all CTD modules, validates against 21 CFR Part 314 requirements, and generates a submission-ready eCTD package.
Generic drug regulatory documentation and bioequivalence packaging. Comparative dissolution data, bioequivalence study reports, and labeling reviewed against reference listed drug requirements.
Single dossier adapted for CDSCO, FDA, and EMA simultaneously. RegIntel handles agency-specific formatting, local labeling requirements, and staggered submission timelines in one workflow.
RegIntel is purpose-built for pharmaceutical regulatory affairs — not a general AI with a regulatory prompt bolted on.
eCTD Module Generation — Produces Modules 1–5 in eCTD format, complete with backbone XML and leaf documents
Gap Analysis Reports — Identifies missing sections, outdated references, and non-compliant statements before submission
IND / CTA Support — Handles early-phase investigational new drug applications and clinical trial authorisations
Label Review — Compares proposed labeling against approved reference standards and agency-specific requirements
Deadline Tracking Dashboard — Visualises all active submission deadlines with escalation alerts configurable by team role
Change Management — Tracks post-approval changes and generates CBE/PAS supplements as required
Multi-Product Portfolio View — Manages multiple compounds simultaneously across their individual regulatory timelines
Audit Trail — Every AI-generated section logged with source citations, version history, and reviewer sign-offs
See how RegIntel reduces dossier assembly time by 65% and eliminates missed deadlines across your global submission portfolio.
Request a Demo → Launch RegIntel ↗