From CDSCO submissions to WHO-GMP compliance and pharmacovigilance — VelorQ's NOVA model handles the regulatory and compliance workflows that define pharmaceutical operations.
Regulatory requirements multiply across markets. Submission timelines compress. Safety signal monitoring never stops. Traditional manual processes can't keep pace.
Preparing a CTD dossier for CDSCO, FDA, or EMA involves hundreds of documents, strict formatting requirements, and cross-referencing between study reports, labels, and clinical data summaries. Each new market multiplies this work.
Safety signal detection requires continuous surveillance of adverse event databases, literature, and spontaneous reports. Manual review at scale is error-prone and resource-intensive — and missing a signal has consequences far beyond the regulatory fine.
WHO-GMP and Schedule M compliance requires continuous documentation, deviation tracking, CAPA management, and audit trail maintenance across manufacturing sites. A single audit finding can halt production.
Four AI agents and tools covering regulatory intelligence, compliance documentation, safety monitoring, and operational analytics — built for Indian and global pharma regulatory contexts.
Monitors CDSCO, FDA, and EMA regulatory updates in real time. Extracts actionable requirements, maps them to your product portfolio, and generates compliance briefs — so your RA team focuses on strategy, not surveillance.
Learn more →Automates WHO-GMP and Schedule M compliance documentation, deviation tracking, and CAPA evidence packaging. Keeps manufacturing sites audit-ready and accelerates inspection responses.
Learn more →Handles medical information queries from HCPs, safety reporting workflows, and internal regulatory helpdesk requests — providing accurate, source-cited responses based on approved labelling and regulatory data.
Learn more →Aggregates regulatory submission timelines, approval rates, safety signal trends, and GMP KPIs into executive dashboards. Connects to your regulatory information management system for live intelligence.
Learn more →These are the regulatory and compliance workflows our pharmaceutical customers activate within the first 30 days.
A mid-size Indian generics company uses RegIntel to prepare new drug applications for CDSCO. The system auto-structures CTD modules from existing study reports, flags missing sections, and cross-checks against current CDSCO guidance — cutting dossier preparation from 4 months to 3 weeks.
A pharmaceutical company's PV team uses RegIntel's signal monitoring to continuously scan WHO VigiBase, FAERS, and EudraVigilance for adverse event patterns associated with their product portfolio — surfacing signals that match predefined criteria for expedited review.
Before a WHO pre-qualification inspection, AccredPrep scans SOP repositories, batch records, deviation logs, and CAPA databases — generating a gap analysis against WHO-GMP requirements and producing an inspection-ready evidence package for each section of the inspection protocol.
Reduction in regulatory submission preparation time
Safety signal turnaround from detection to brief
Average time to WHO-GMP inspection readiness
Regulatory markets covered — CDSCO, FDA, EMA — from one platform
Book a 30-minute demo for your specific regulatory context — CDSCO submissions, WHO-GMP compliance, or pharmacovigilance. We'll show real output, not a deck.