IRISYS is a contract development and manufacturing organization (CDMO) headquartered in San Diego that helps biotech and pharmaceutical firms manufacture clinical drugs, drug delivery technologies, and formulations for rare diseases and orphan drugs, and get them approved by the FDA. When IRISYS contracts with partner firms, they assist with R&D, manufacturing, and regulatory processes. In addition to this, the company also has a small product portfolio of its own that includes the SCOT-TUSSIN family of sugar-free and alcohol-free cough medicines.

Founded in 1996, IRISYS had been relying on a paper-based quality management system for many years. When the company started to scale rapidly a few years back, they quickly realized their paper-based system simply couldn’t keep pace with their fast-growing operations. Seeking a better way forward, IRISYS sought to modernize their operations by moving to an electronic quality management system (eQMS). After doing their due diligence, they moved their quality management system to Qualio, and they haven’t looked back since.

Read the Case Study: IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval


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Published by Robert Fenton November 3, 2020
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