Our Quality Assurance services aim to minimize operational risks and to identify opportunities for improvement. We are proud of our track record to effectively guide our clients to establish their own PV systems or clinical operations to maintain high-quality activities.
QA consultancy services we provide include:
- Inspection readiness and post-inspection support
- Quality Management System (QMS) analysis, review and improvements
- Standard Operating Procedure (SOP) review and improvements
- Risk management and audit program consulting
- Supporting signal management activities along with building, developing and improving in-house processes.
- Management of Corrective Actions and Preventative Actions (CAPA)
- Identifying Key Performance Indicators (KPI)
- Pharmacovigilance or other document audits for QA and compliance such as Integrated Summaries of Safety and Efficacy (ISS/ISE) Reports, Clinical Study Reports (CSRs)
- Training Review and Support
We also perform QA Audits for vendors to evaluate qualifications and capabilities, to reassess a vendor to provide assurance that the vendor remains qualified or to assess the vendor’s adherence to their processes and applicable regulations and guidelines while conducting work for a sponsor.