GxP Auditing, Inspection Readiness & Quality Consulting
We provide GxP auditing services, Inspection readiness support, and Quality consulting services
GxP Auditing, Inspection Readiness & Quality Consulting
We provide GxP auditing services, Inspection readiness support, and Quality consulting services
Your Challenge
Conducting Pharmacovigilance (PV), Good Clinical Practice (GCP) and Good Manufacturing practice (GMP) Good Distribution Practices (GDP), Medical Device regulations (MDR)
Audits:
- Audit Preparation
- Audit Conduct
- Audit Reporting
Our Expertise
- Development of audit plans, audit agendas, pre-audit requests for information, and audit reports and tools
- Preparation of PV audit plans, issuance of pre-audit requests for information and preparation of audit agendas, including review of documentation in preparation for the audits, as necessary.
- Perform PV audits: lead or co-support the audit conduct
- Prepare and submit an initial draft audit report.
- Finalise and submit the final audit report.
- Issuance of the final audit reports to the auditees
- Mock inspection – as preparation for inspection
Your Challenge
Quality Management System establishment
Our Expertise
- Development of Standard Operating Procedures (SOPs) according to ISO 9001:2015 and ISO 27001
- Gap assessment of existing procedures
- Preparation for ISO certification
- Review and/or development and support for issue management
- Cybersecurity audit and consulting
- Any other consultancy services tailored to your needs
Your Challenge
Quality Management System establishment
Our Expertise
- Development of Standard Operating Procedures (SOPs) according to ISO 9001:2015 and ISO 27001
- Gap assessment of existing procedures
- Preparation for ISO certification
- Review and/or development and support for issue management
- Cybersecurity audit and consulting
- Any other consultancy services tailored to your needs
Your Challenge
Any other ad hoc activities
Our Expertise
- Assisting in CE mark registration including end to end project management (comunication with notified bodies, documents, presentations etc)
- Support during audits/inspections
- Any required training for the PV/non PV personal
- Vendor/distributor audits – vendor qualification, selection and management
- Any consultancy required etc.
