Expertise
Supplier Quality & Audits
You remain accountable for materials and operations you outsource. We build supplier quality programs that are proportionate to risk, and we perform audits that produce usable findings rather than a checklist.
Supplier quality services
- Supplier qualification and risk classification programs
- GMP audits of API, excipient, component and packaging suppliers
- Contract manufacturer and contract laboratory audits
- Quality agreement development and negotiation support
- Supplier performance monitoring, scorecards and periodic requalification
- Supplier corrective action follow-up and disqualification decisions
- Internal audit program design and execution
Due diligence quality audits
Before an acquisition, licensing deal or site transfer, quality liabilities are frequently the least understood part of the transaction. We conduct focused due diligence assessments of quality systems, validation status, data integrity posture and compliance history, and we report what the findings would cost to remediate.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.