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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Project management
Planning and coordination for GMP-related projects, from quality-system upgrades to remediation programmes.
Compliance projects fail when ownership, sequencing and resourcing are unclear. We provide project leadership that keeps remediation plans, facility programmes and system implementations on schedule and within the agreed scope.
Typical engagements
- Post-inspection remediation programmes
- Quality-system implementation or re-engineering
- Technology transfer and new product introduction support
- Facility upgrade and qualification programmes
How we approach it
Clear ownership
Every workstream has a named owner and a defined outcome.
Regulatory-aware sequencing
Activities are ordered so that commitments to regulators are met on time.
Transparent reporting
Status, risks and decisions are reported in a form leadership can act on.
Related services
Consulting
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.
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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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