A combination product company needed to rapidly develop GMP-compliant electromechanical autoinjectors for an upcoming clinical trial. Kymanox provided end-to-end product development services, delivering fully integrated device design, comprehensive technical documentation (including DHF), CGMP-compliant manufacturing systems, and complete quality documentation—all within an aggressive 14-month timeline. The result was successful on-time trial initiation and demonstration of Kymanox’s capability to deliver complex, high-quality combination products with speed and reliability.
CHALLENGE
SOLUTION
RESULTS
- Design, fully document, and manufacturing CGMP-compliant electromechanical autoinjectors from the ground up.
- Meet the challenging goal of supplying qualified devices for a first-in-human clinical trial within just 14 months.
- Ensure all design, documentation, and quality system requirements are met for regulatory compliance and patient safety.
- Delivered a fully integrated project approach, encompassing device concept, engineering design, analysis, risk management, and verification testing.
- Developed and implemented a complete manufacturing quality system compliant with CGMP, enabling in-house production of clinical trial materials.
- Authored comprehensive technical documentation, including Design History File (DHF), quality system documents, and manufacturing records.
- Seamlessly coordinated all aspects (design, prototyping, testing, and regulatory manufacturing) within the Kymanox team to eliminate delays and communication gaps.
- Client received fully compliant autoinjectors on an aggressive timeline, enabling on-schedule initiation of their human clinical trial.
- Successful trial execution yielded valuable insights for the evolution of their technology platforms, supporting future development and patient benefit.
- Demonstrated Kymanox’s capability to deliver complex, high-quality combination products rapid and reliably.