Is your combination product really submission-ready?

Published: 12-Nov-2026 Featured companies: NSF
Regulatory Drug Delivery Medical Devices

A pharmaceutical team may consider a combination product nearly ready because the clinical, stability, quality, and drug data are in place. At the same time, the device team may still be completing design verification, usability studies, risk-management activities, or notified-body preparation

Promoted Content Is your combination product really submission-ready?

Both workstreams can appear to be on schedule while using different definitions of readiness.

In this clip, Maria O'Callaghan explains why these differences often become visible only during submission preparation. This is when gaps in evidence, documentation, responsibilities, and timelines must be resolved within one integrated product story.

The most successful programs establish a shared definition of success early. The objective is not simply to complete two task lists by the same date. It is to create one coherent, submission-ready combination product.

To watch the full discussion visit: https://nsf.ondemand.goldcast.io/on-d...

To assess whether your combination product is truly submission-ready, contact NSF Life Sciences at lifesciences@nsf.org. 

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Founded in 1944, NSF’s mission is to protect and improve global human health. NSF, Pharmaceutical Services provides a comprehensive range of independent, third-party...
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