The recently published combination product regulation requires the merging of previously independent development processes (drug/biologic and device) into a single, integrated and holistic process.  Combination product development requires that Quality and R&D organizations, as well as outsourced partners, all understand how their contributions are part of larger "system" and not just an independent component. We have been an extension to numerous combination product programs resulting in time saved and documentation that meets regulations.

Develop an integrated Combination Product