Qualio is a cloud-based quality management software (QMS) system designed specifically for life science companies. It empowers organizations in medical devices, pharmaceuticals, biotechnology, and contract research to accelerate time to market, increase revenue, and reduce risk. Qualio's software helps embed and automate compliance with regulatory standards like FDA, ISO, and GxP. The platform unites teams, processes, and data into a single source of truth, fostering a quality culture and enhancing business competitiveness. The company is headquartered in San Francisco, California, and employs between 51 and 200 people.
Qualio was founded in 2012 by Robert Fenton. Since inception, the company has grown to serve over 650 life sciences companies across 80 countries. The firm focuses on providing a scalable, trusted electronic quality management system (eQMS) that supports the entire life sciences ecosystem, enabling faster and safer product launches. Its growth has included doubling its customer base year-over-year and expanding its business and technology integration capabilities.
The company has focused on expanding its product's integration capabilities and enhancing its consulting partner program to support broader life sciences quality management needs and faster scaling.
Qualio has been actively improving its platform with an emphasis on business and technology integrations. Recent expansions include better connectivity for integrated workflows and enhanced partner programs. The company also emphasizes usability improvements to support rapid growth and complex regulatory environments in the life sciences sector.
Qualio operates as a fully remote company committed to accelerating life science teams to faster product launches, smarter scaling, and seamless compliance. Senior leadership reflects a commitment to customer-centric growth, building trust, and supporting a quality-driven culture. The company values empowerment of customers to produce effective, consistent, and safe products that improve lives globally.
Qualio boasts a user base of more than 650 life sciences companies across 80+ countries. Its customers span pharmaceutical, biotech, medical devices, and contract research organizations. The company actively supports a global all-remote team and community focused on quality management and regulatory compliance, enabling them to scale life-saving products efficiently without sacrificing speed.
