Qualcy eQMS provides simple interface for managing AI (artificial intelligence) based Regulatory Intelligence for Pharma & Biotech Companies. Stay Ahead of Regulatory Change and Take Proactive Actions
AI based Regulatory Intelligence (Reg Intel) is the continuous process of collecting, analyzing, and applying regulatory data and trends to support strategic decision-making throughout the product lifecycle. From early development to post-market surveillance, Reg Intel ensures that your organization stays compliant, efficient, and informed in an increasingly complex global environment.
Why Regulatory Intelligence Matters
- Regulatory guidelines are dynamic — failing to track them can delay approvals or result in costly non-compliance.
- Pharma and biotech companies must navigate differing standards across global markets.
- With regulatory intelligence, you gain visibility into emerging trends, competitor strategies, and agency expectations.
- Make faster, smarter decisions across your R&D, clinical, and regulatory affairs teams.
Qualcy Core Services
- AI Global Regulatory Monitoring
Track evolving requirements from agencies such as the FDA, EMA, MHRA, PMDA, NMPA, and others. Receive real-time updates tailored to your therapeutic area and geography. - AI Competitive Intelligence
Analyze Regulatory filings, approval timelines, and regulatory strategies to better position your pipeline and optimize submissions. - Strategic Planning Support
Align regulatory strategies with development milestones, reduce risks of rework, and accelerate time-to-market. - Knowledge Sharing: AI Custom Alerts & Insights
Receive intelligent, actionable alerts based on market changes, guidance updates, advisory committee recommendations, Dashboards, newsletters and more.
