Small, mid-size and enterprise organizations in Pharmaceuticals, Healthcare across 4 countries.
What is Qualio?
Qualio offers a cloud quality management and compliance platform for life sciences organizations, including medical device, SaMD, pharmaceutical and biotech companies. The software handles document control, training, CAPA, design controls and risk management, and adds AI agents that run gap analyses against FDA, ISO and EMA requirements and track regulatory changes. Qualio was founded in Dublin in 2012 and is now headquartered in San Francisco, keeping an office in Dublin. The company says more than 500 life sciences companies use the product, from early startups to larger pharma organizations.
Services and products
- Document control
- CAPA process
- Design controls
- Risk management
- Training management
- Regulatory gap analysis with AI agents
- Audit readiness dashboards
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