Situation:
A class 3 cardiovascular device company had significant concerns about its ability to withstand regulatory agency scrutiny.
Solutions:
- A gap analysis identified significant issues with internal quality systems and external vendor oversight.
- Halloran supported the newly hired VP of Regulatory, Clinical and Quality to close the gaps.
- Halloran conducted for cause inspections of research sites with potential fraud issues.
- Ongoing consulting and augmentation to support skills and resolve potential issues with the team before they become problems.
Value:
Internal operations are proceeding without obvious risks due to the quality and compliance framework within which to operate.