GMP readiness assessments
A clear-eyed evaluation of where your supply chain stands - and what it needs to be inspection-ready.
The problem
You have a GMP milestone, a filing deadline, or a pre-approval inspection approaching. But you're not sure if your supply chain is actually ready. Are supplier qualifications complete? Is design transfer documentation sufficient? Will traceability hold up?
The worst time to find out is during the inspection. The best time is now.
My approach
I assess your supply chain against what an inspector actually looks for - not theoretical ideals. Supplier qualification status, materials documentation, design transfer completeness, traceability systems, and filing readiness. The output is a gap report with prioritized action items classified by regulatory risk.
What I deliver
Supply chain gap assessment
Review of every supplier against GMP qualification requirements.
Documentation completeness review
Evaluation of design transfer records, qualification reports, materials data, traceability.
Prioritized action plan
Risk-ranked gaps with remediation steps, owners, and timelines.
Filing readiness evaluation
Assessment of CMC documentation against your specific submission requirements.
Who this is for
Biotech and cell therapy companies with GMP milestones approaching. Programs preparing for inspections. Quality teams wanting an independent assessment before filing.