The combination product market has unique challenges but is one of the most transformational areas of Life Sciences. Predictions determine that combination products (Rx, Dx, Device) are going to be the majority of products entering the changing regulatory and payor world in the future.
With this increase in market size and the substantial regulatory demands and uncertainty, it is critical to bring to bear expertise with knowledge across regulatory domains and understanding of the scientific principles behind the technology. It is not enough to hire individual domain experts.
Having been involved in combination products since the beginning, QIS provides these essential integrated capabilities and is uniquely positioned to help clients navigate the challenges faced by combination product sponsors.