Consulting
Project management
Planning and coordination for GMP-related projects, from quality-system upgrades to remediation programmes.
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Quality-management-system solutions, facility and system audits, regulatory inspection preparedness, supplier auditing and qualification, and process review and improvement for the pharmaceutical and life-sciences industry.
Consulting
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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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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Auditing
Facility and system audits
Independent GMP audits of facilities, utilities and quality systems, reported with clear findings and practical recommendations.
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Supplier auditing and qualification
Audits and qualification programmes for API, excipient, packaging and service suppliers across your supply chain.
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Due diligence
Independent assessment of regulatory compliance, quality systems and risk for acquisitions, partnerships and contract manufacturing decisions.
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GMP Services
Quality Management System solutions
Design, implement and strengthen a pharmaceutical quality system that meets regulatory expectations and works for the people who run it.
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Quality Risk Management
Practical quality risk management that identifies, assesses and controls risks to product quality and patient safety.
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On-site training, including new hires
Role-specific GMP training delivered at your facility, with induction programmes for new starters.
Learn moreNot sure which service fits your situation?
Tell us about your site, products and target markets and we will recommend a scope.
Not sure which service fits your situation?
Tell us about your site, products and target markets and we will recommend a scope.