Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus over time. Companies move from toxicology studies through IND-enabling activities, and from preclinical and clinical testing through commercialization. Tasks and objectives change, but the need for speed, precision, flexible thinking, and CMC expertise remain.
CMC leaders must define and execute strategies for process, product, and analytical methods. They focus on formulation, characterization, and stability programs, while often working with lean teams and gated resources. Whether generating submission-enabling data, troubleshooting technical challenges, or grappling with GMP requirements, your effort will be more successful when driven by CMC strategies developed for your business and technology, and supported by extensive knowledge and best practice.
This info sheet details Converge’s CMC expertise for our clients.