Supplier qualification
Turning contract manufacturers into qualified, GMP-ready suppliers - with the documentation to prove it.
The problem
Your suppliers ship components, but there's no quality agreement. No formal specs. No incoming inspection criteria. The relationship is informal - closer to a purchase order than a qualified supplier program. And you have a filing deadline.
My approach
Phase-appropriate. What you need at Phase I is different from commercial. Early-stage gets right-sized documentation. Commercial gets the full suite. For each supplier, I assess quality system maturity, define scope based on component risk, and build the documentation package.
What I deliver
Supplier risk assessment
Classification by component criticality, quality system maturity, and regulatory impact.
Quality agreements
Drafted and negotiated - responsibilities, change notification, complaint handling, audit rights.
Component specifications
Formal specs with acceptance criteria, test methods, and sampling plans.
Supplier assessments
Desktop evaluations, questionnaires, or full audit reports depending on risk.
Incoming inspection
Procedures, sampling plans, and acceptance criteria your team can actually execute.
Ongoing monitoring
Scorecards, periodic review procedures, and re-qualification triggers.
Who this is for
Companies with supplier networks that grew organically and need formalization. Programs preparing for inspections. Expanding from clinical to commercial with growing supplier portfolios.