GMP Services
Quality Risk Management
Practical quality risk management that identifies, assesses and controls risks to product quality and patient safety.
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Quality Management System solutions
Design, implement and strengthen a pharmaceutical quality system that meets regulatory expectations and works for the people who run it.
A quality management system is only effective when its procedures match how a site actually operates. We work with your quality and operations teams to assess the current system, close the gaps between documentation and practice, and build the governance, metrics and review cycles that keep it current.
Where this helps
- New facilities that need a complete, inspection-ready quality system
- Established sites whose procedures have grown inconsistent over time
- Companies preparing to supply regulated markets for the first time
- Organisations responding to inspection observations about quality-system effectiveness
How we work
We start with a structured assessment against the applicable GMP framework and ICH Q10, then agree a prioritised improvement plan. Procedures are drafted with the people who will use them, trained in, and verified through self-inspection before the system is declared effective.
How we approach it
Assessment first
Every engagement starts with a gap analysis so effort goes where the compliance risk is highest.
Built with your team
Procedures are written with the owners who will operate them, not handed down.
Verified, not just documented
We check that the system works in practice through self-inspection and metrics review.
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GMP Services
On-site training, including new hires
Role-specific GMP training delivered at your facility, with induction programmes for new starters.
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