Development services are conducted with a GMP mindset and a focus on product manufacturability and quality. This entails considering product administration, stability, and processing requirements from the start. Clients and project sponsors realize numerous benefits from the focus on lyophilization, with access to a comprehensive range of services available from a single source.
Following applicable GMP principles, the development and process laboratories are well equipped for conducting a diverse range of experiments encompassing formulation development, cycle design, process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale manufacturing environment. Critical areas for fill/finish are all within a certified HEPA environment, emulating aseptic operations for sterile product. Our comprehensive development reports readily support your regulatory submissions.
When you’re ready to engage, capitalize, and benefit from our expertise, flexibility, and reliability contact us so we can start your product development on the path to success.