Why GMPKit is Different
When your manufacturing network is in crisis, you need proven expertise combined with fresh thinking—not generic consulting, not experimental approaches.
Restore operational stability in 90–120 days. GMPKit converts strategy into disciplined execution to slash the Cost of Poor Quality (COPQ) and deliver planned, predictable batch flow.
The Pragmatic Innovator
We're not rogue, but we're definitely different. GMPKit brings new ideas and new ways of working, grounded in proven methodologies and 40+ years of pharmaceutical operations experience.
We Execute, Not Just Advise
Traditional consultants deliver slides and recommendations. We partner with your site teams to implement solutions, working alongside your people to ensure adoption and results.
We Focus on Crisis Response
When your manufacturing network is failing—batch failures, inspection findings, deviation backlogs—we execute rapid operational recovery in 90-120 days, not 6-12 months.
We Bring Fresh Thinking
We introduce new ideas and new ways of working to your team—not experimental approaches, but proven methodologies grounded in LEAN principles and Theory of Constraints.
We Assume Accountability
Unlike consultants who deliver reports and leave, we assume responsibility for results. We measure success by your operational stability, not our deliverables.
GMPKit vs. Traditional Consulting
We're a consulting + agency hybrid. We don't just tell you what to do—we partner with your teams to execute solutions and deliver results.
Crisis Response, Not Long-Term Transformation
GMPKit
90-120 day operational recovery focused on immediate stability
Traditional Consulting
6-12 month transformation programs with uncertain timelines
Execution, Not Just Advice
GMPKit
Partner with your site teams to implement solutions hands-on
Traditional Consulting
Deliver recommendations and leave implementation to you
Accountability for Results
GMPKit
Assume responsibility for outcomes, not just deliverables
Traditional Consulting
Deliver slides and reports, then move to next client
Rapid Deployment
GMPKit
Weeks to diagnose, days to deploy, 90-120 days to results
Traditional Consulting
Months of assessment before any action is taken
Fresh Thinking + Proven Methods
GMPKit
New ideas grounded in LEAN principles and 40+ years of experience
Traditional Consulting
Generic frameworks applied across all industries
Pharmaceutical Manufacturing Specialists
GMPKit
Deep GMP expertise—we've lived your challenges
Traditional Consulting
Generalist consultants learning your industry on your dime
The 90-120 Day Commitment
When your manufacturing network is in crisis, you can't wait 6-12 months for results. Our engagements are designed to restore operational stability in 90-120 days.
Rapid Diagnostics
Identify root causes and quick wins in weeks, not months
Strategy Deployment
Convert goals into disciplined execution systems
Hands-On Execution
Partner with site teams to implement solutions
Governance Systems
Sustain improvement after we leave
Our Promise:
By day 120, you'll have measurable results: reduced COPQ, predictable batch flow, and inspection-ready performance. Not a slide deck—actual operational stability.
Crisis Scenarios We Solve
GMPKit specializes in rapid operational recovery for pharmaceutical manufacturing networks in crisis.
Batch Failures
Your batch success rate is declining, COPQ is climbing, and you're losing revenue with every failed batch.
We restore batch reliability through LEAN-based governance systems and disciplined execution.
Inspection Findings
FDA or regulatory findings have exposed systemic issues in your manufacturing operations.
We execute rapid remediation plans that address root causes, not just symptoms.
Deviation Backlogs
Your deviation backlog is growing faster than you can investigate, delaying batch disposition.
We implement structured investigation processes that prevent deviations and clear backlogs.
Scale-Up Challenges
Your CDMO is struggling to scale from clinical to commercial manufacturing volumes.
We deploy proven scale-up methodologies that deliver predictable batch flow at volume.
40+ Years of Pharmaceutical Manufacturing Expertise
We don't just understand pharmaceutical operations—we've lived them. This allows us to introduce proven methodologies that traditional consultants overlook.
Years of Experience
Cross-disciplinary expertise in Manufacturing, Quality Assurance, IT, and Operational Technologies
Pharmaceutical Focus
We only work with pharmaceutical and biotech manufacturers—no generic consulting
Days to Results
Rapid operational recovery, not long-term transformation programs
Ready to Restore Operational Stability?
When your manufacturing network is in crisis, you need proven expertise combined with fresh thinking. Let's discuss how GMPKit can execute rapid operational recovery in 90-120 days.