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IntelleScope is a regulatory intelligence platform built from the ground up for biotech and pharmaceutical teams. We ingest over 328,000 FDA regulatory documents across 11 data sources — including 510(k) clearances, PMA approvals, drug approvals, warning letters, recalls, guidance documents, and 21 CFR regulations — and structure them for AI-powered search, personalised dashboards, and automated workflows. Unlike legacy platforms that bolt AI onto decades-old databases, IntelleScope is AI-native: smarter search, cross-document regulatory synthesis, and AI agents that do the regulatory work for you.
Regulatory intelligence software helps life sciences companies monitor, analyse, and act on regulatory changes from agencies like the FDA, EMA, and MHRA. It replaces manual tracking of approvals, guidances, warning letters, and recalls with automated monitoring, AI-powered search, and personalised alerts — enabling regulatory affairs teams to stay compliant and make faster decisions.
IntelleScope monitors over 328,000 FDA documents across 11 regulatory data sources — including 510(k) clearances, PMA approvals, drug approvals (NDAs, BLAs, and ANDAs), warning letters, untitled letters, drug and device recalls, guidance documents, 21 CFR regulations, and FDA facility registrations covering 24,000+ establishments. The platform ingests data directly from FDA sources and structures it for AI-powered search, filtering, and personalised alerts.
IntelleScope is AI-native — built from the ground up with AI at its core, not retrofitted onto a legacy database. This means smarter search, cross-document synthesis, and AI agents that do the work for you. IntelleScope is also designed for mid-market biotech and pharma teams, not just large enterprises, with pricing and workflows built for smaller regulatory affairs teams.
IntelleScope is designed for regulatory affairs professionals, quality and compliance teams, and R&D leaders at biotech and pharmaceutical companies. It is particularly suited for mid-market teams that need enterprise-grade regulatory intelligence without the cost and complexity of legacy platforms.