Case Studies
90-120 day transformations that deliver measurable results.
Real engagements with pharmaceutical manufacturers facing COPQ challenges, batch failures, and operational crises.
These are not marketing stories.
They are documented operational recovery engagements.
Measurable outcomes. Reduced COPQ. Restored execution stability.
Showing 2 case studies
Inspection Readiness Case Studies
Mock Audit Strengthens FDA Inspection Readiness
July 21, 2026
A mock audit identified subtle operational inconsistencies that could increase inspection exposure during a future FDA inspection. The engagement provided leadership with a prioritized roadmap to strengthen inspection readiness and improve the defensibility of existing laboratory controls.
Backlog Reduction Case Studies
How a Cell Therapy Site Restored Execution Stability and Eliminated a Deviation Backlog Without Adding Headcount
May 26, 2026
A growing deviation investigation backlog at a cell therapy manufacturing site had halted clinical product release, eroded client confidence, and overwhelmed operational teams with investigation rework. GMPKit applied a structured operational recovery framework focused on investigation quality, governance, and execution stability—eliminating the backlog without adding headcount, restoring clinical supply flow, rebuilding client confidence, and generating more than $3.5 million in operational and financial impact.