Case Study

Premarket Regulatory Issues

The Situation

Company: Small Pharma

Issue: Significant premarket regulatory issues with wearable infuser/on-body delivery system (OBDS) over several years with a major need to reach the market and realize return on investment.

Project: Regulatory support for submission and regulatory engagement, including review/revision/contributions to eCTD filing as well as work with the device partner organization.

Challenges Expressed:

 

  • Complex documentation structure, split between multiple parties (pharma client and device partner).
  • Unique challenges presented by a device constituent that includes electromechanical and software elements.
  • Relatively novel combination product type (OBDS) with equally limited precedent.
  • Evolving regulatory requirements and expectations that had shifted since the initial product submission.
  • Changes previously made to the device constituent to address regulatory concerns, leaving little time or resources for additional modifications.
  • Time sensitivity given delays and a need for significantly higher probability of success.

Impact:

  • Failure to meet timeline or additional regulatory issues could have had material effect on the company.

Discovery:

  • Internal team had relatively limited resourcing and experience.
  • Submission documentation did not facilitate regulatory review.
  • Challenges existed within the pharma client/device partner relationship.
  • Issues related to the ‘combination product’ – not purely drug or device, but the interface/interaction of both.
  • Internal resourcing was constrained and needed to address the source of many issues while attempting to prepare for commercialization.

Solutions Implemented:

  • Revamped regulatory submission to be cohesive and coherent given the manner in which combination products are reviewed.
  • Drove collaboration between the pharma client and device partner to achieve alignment and success.
  • Utilized subject matter experts to evaluate and refine content on specific issues (e.g. Human Factors, software, electromechanical device standards compliance).
  • Supplemented and integrated with client’s team to enable on-time delivery of the materials needed for submission.
  • Interpreted and formulated responses to regulatory feedback throughout the project.