Device submissions for combination products: a data-driven perspective

AdobeStock_172846643 (1)

The rapid increase in novel therapies and innovative drug delivery methods particularly in the context of combination product regulatory submissions, requires the management of a significant amount of data between sponsors and regulators. Challenges arise when there is a lack of robust data management, and these challenges suggest a need to develop data-driven approaches for successful submissions and reviews. This article explores how data-driven approaches impact device submissions for combination products, highlighting challenges and opportunities that can be leveraged in the evolving regulatory landscape.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to registered users and TOPRA members.

Already a member or have an account? Sign in.

Members login

Included with TOPRA membership

Already a TOPRA member?

Using your MyTOPRA credentials, log-in now for unlimited access to all Regulatory Rapporteur journal articles, online archive and the latest industry news and content.



Free access to selected content

Register to continue to access industry news, podcasts and commentary plus one member-only journal article each month. You will still be able to view editorials and contents pages without restriction.

  • Create your own library to save your favourite content.
  • Sign up for Regulatory Rapporteur email newsletters.
Create a free account


TOPRA membership

Become a TOPRA member and join our global community of regulatory affairs professionals.

  • Great savings on our events and training.
  • Be part of our dynamic international community.
  • Contribute to the profession.
  • Grow your skills and knowledge.
  • Take your career to the next level.
Become a member