Case Study

Regulatory Strategy

The Situation

Company: Medium-sized Pharma developer of novel cancer therapeutics

Issue: Required subject matter expert support for dosing emulsion preparation and dosing kid commercial development and strategic leadership engagment to resolve knowledge and alignment roadblocks.

Project: Device DHF development and regulatory strategy/planning for commercial submission.

Challenges Expressed:

  • The company’s Quality department provided unclear and improper direction to the cross-functional team
  • Day-to-day activities for the program seemed to be experiencing consistent delays
  • The DHF documentation process was taking longer than desired or necessary

Impact:

  • Delayed regulatory submission
  • Delayed launch, and therefore revenue
  • Increased costs
  • Lack of trust between internal client departments

Discovery:

  • Quality department had limited device and combination product development experience
  • Quality department leadership involvement in core team activities was slowing down processes
  • CMC and Quality organizations were misaligned on development strategy
  • DHF documentation strategy included excessive documentation review cycles
  • More communication and functional cross-training for client department leaders was needed

Solutions Implemented:

  • Developed DHF and device submission documents for successful FDA approval
  • Provided Quality leadership with opportunity to discuss and align on documentation strategies prior to developing with core team
  • Established touchpoints with client department leaders to enable an escalation path and provide opportunities for training on specific topics of concern
  • Identified influencers within the quality organization and enabled peer relationships to establish confidence with quality leadership