ABSTRACT
In Chapters 3 and 4, we presented not only the need for a rigorous approach in developing combination products and gaining regulatory approval for them, but also the knowledge necessary to accomplish those. Since the development of combination products must critically consider other requirements, this chapter takes into consideration not only the technological challenges but also a much-needed focus on the development and implementation of support systems for combination products (CPs). These include, but are not limited to, IT resources, technical resources, facilities, quality, regulatory, clinical, and manufacturing system challenges.
