CQV Consultants
CQV Consultants Limited is a UK-based firm providing a wide range of consulting services with expertise in GMP compliance, facility and equipment qualification, change management, investigations, and healthcare remediations. They focus on solving critical issues for clients in the pharmaceutical, biotechnology, and API manufacturing industries, aiming to help organizations achieve GMP compliance and inspection readiness.
Industries
Nr. of Employees
small (1-50)
Services
Advisory and hands-on consulting to achieve and maintain GMP compliance for pharmaceutical, biotechnology, and API manufacturers.
Execution of commissioning and qualification activities for new equipment, clean utilities, and facilities, including preparation of DQ/IQ/OQ/PQ and related documentation.
Preparation for regulatory audits and inspections, including gap assessments and remediation planning to address inspection findings.
Investigation of out-of-specification results and implementation of corrective and preventive actions to address root causes.
Support to plan and execute remediation activities to meet US FDA and EU GMP requirements following inspections or internal assessments.
Services to implement and manage change control processes and oversee supplier/vendor quality assurance to align with GMP requirements.
Advisory and hands-on consulting to achieve and maintain GMP compliance for pharmaceutical, biotechnology, and API manufacturers.
Execution of commissioning and qualification activities for new equipment, clean utilities, and facilities, including preparation of DQ/IQ/OQ/PQ and related documentation.
Preparation for regulatory audits and inspections, including gap assessments and remediation planning to address inspection findings.
Investigation of out-of-specification results and implementation of corrective and preventive actions to address root causes.
Support to plan and execute remediation activities to meet US FDA and EU GMP requirements following inspections or internal assessments.
Services to implement and manage change control processes and oversee supplier/vendor quality assurance to align with GMP requirements.
Expertise Areas
- GMP compliance and inspection readiness
- Facility and equipment qualification
- Quality systems and CAPA
- OOS investigation and remediation
Key Technologies
- DQ/IQ/OQ/PQ validation protocols
- Validation master planning (VMP) and URS development
- Audit and inspection readiness methodologies
- CAPA and root-cause investigation methods