Our History
Founded in 2001, Title21 helps healthcare and life sciences organizations operate with greater confidence, quality, and care. Its name, inspired by Title 21 of the Code of Federal Regulations, underscores a commitment to patient safety, regulatory compliance, and operational excellence.
As the industry evolved, Title21 expanded beyond compliance to support cellular therapy labs, blood and marrow transplant programs, and biotherapeutic manufacturers. The company has remained committed to its mission: simplifying complex processes, improving quality, and enabling vital work.
In 2026, Title21 experienced significant growth by acquiring MyCellHub, a manufacturing execution system for advanced therapies. This acquisition introduced real-time production monitoring, digital batch records, and integrated quality management.
Later in 2026, Title21 acquired cResults, a leader in quality operations software. Over two decades, cResults developed its Smart-QX suite to address challenges in planning and scheduling personnel, resources, and testing for quality operations. This acquisition enhanced Title21’s capabilities in resource planning, regulatory intelligence, and AI-powered document review, resulting in shorter cycle times, improved on-time delivery, and greater resource efficiency.
Today, Title21 is creating a more connected future for advanced therapies by integrating quality, manufacturing, clinical, and operational planning into a single digital suite. This approach reduces risk, increases efficiency, and accelerates the delivery of life-saving therapies to patients.
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Our Mission
Title21 believes biotherapies are the future of medicine and the industry needs higher quality and better access to tools and data to discover and deliver cures to patients. Our role is to design and implement software that bridges the gap between clinical practice, laboratory science, and therapeutic manufacturing, empowering our customers to serve patients with quality, efficiency, and kindness in mind. Ultimately, Title21 is proud to enable and enhance the execution of workflows and the collection and presentation of data that lets our customers tell their stories and serve their patients.
Our Leadership
Our Commitment to the Future
As the healthcare landscape continues to evolve, Title21 remains committed to being at the forefront of innovation. We are dedicated to investing in research and development, expanding our product offerings, and partnering with healthcare organizations to create a brighter, healthier future for all.
Join Our Team of Innovators
We're a community of problem-solvers and collaborators dedicated to bringing innovative software solutions to patients globally. If you're ready to use your unique talents and make a real impact, explore our open positions and discover a career where your contributions truly matter.
