Our History
Title21 started in 2001 with a clear goal: to help healthcare and life sciences organizations work with more confidence, quality, and care. The company takes its name from Title 21 of the Code of Federal Regulations, reflecting its commitment to supporting organizations responsible for patient safety, regulatory compliance, and operational excellence.
As the industry changed, Title21 grew as well. The company started with a focus on compliance, then expanded to support cellular therapy labs, blood and marrow transplant programs, and biotherapeutic manufacturers. These teams lead in patient care and scientific progress. Throughout this growth, Title21 stayed true to its mission: making it easier for organizations to manage complex processes, improve quality, and continue their important work.
A major milestone happened in 2026 when Title21 acquired MyCellHub, a manufacturing execution system designed for advanced therapy manufacturing. This addition allowed Title21 to offer real-time production monitoring, digital batch records, and built-in quality management for manufacturing operations.
Today, Title21 is working toward a more connected future for advanced therapies by combining quality, manufacturing, and clinical workflows into a single digital suite. The aim is not only to improve systems but also to achieve better results: lower risk, greater efficiency, and faster delivery of life-saving therapies to patients.
2001
100+
12+
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.
