Bring To Market
When it comes to manufacturing our drug/device combination products, kaléo excels at developing and managing a world-class supply chain. We build our products to the highest quality standards on state of the art automated manufacturing lines because we know that when it comes to potentially life-saving products you expect the very best.
Regulatory & Clinical
Our regulatory and clinical team has decades of experience in both U.S. and global regulatory filings. As with other areas of our business, what sets us apart is the way we obtain and use insights from patients and other users as a core part of our submissions.
At kaléo, we conduct clinical studies to meet regulatory requirements. In addition, every product goes through our Human Factors Engineering (HFE) program as part of the development process. HFE includes several rigorous studies, which involve feedback from patients and other intended users. By incorporating HFE into the development process, we are able to create products that are intuitive and easy to use for patients and users.
The kaléo commercial team has over 50 years of experience bringing valuable therapies to patients. Kaléo commercializes its products through two models:
- Commercialize products ourselves in specific therapeutic areas.
- License our products to commercial partners who have the resources and capabilities to help realize their potential.