Consulting
Project management
Planning and coordination for GMP-related projects, from quality-system upgrades to remediation programmes.
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Regulatory inspection preparedness
Mock inspections, gap analysis and coaching so your site and your people are ready for USFDA, MHRA, MFDS, EDQM and other regulatory inspections.
Preparation is what separates a routine inspection from a difficult one. We run realistic mock inspections in the style of the authority you expect, assess the gaps that surface, and coach subject-matter experts and front-room teams on presenting their work clearly and accurately.
What preparation covers
- Mock inspection by experienced auditors, including document requests and interviews
- Gap analysis against the relevant regulatory framework
- Remediation planning and CAPA support
- Front-room and back-room process design
- Coaching for subject-matter experts
- Support during the inspection and with the written response
How we approach it
Authority-specific
Mock inspections reflect the approach of the agency you are expecting.
People as well as paper
We prepare the teams who will answer questions, not only the documents.
Through to response
Support continues into the inspection and the formal written response.
Related services
Consulting
Facility design and validation
GMP input to facility design, and qualification and validation support for new and modified facilities, utilities and equipment.
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Process review and improvement
Structured review of production, laboratory and quality processes to remove bottlenecks and reduce compliance risk.
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Operational excellence
Lean principles, performance measurement and process optimisation applied within a GMP environment.
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