Quality Assurance Services
We provide elevated experiences guided by our aim to deliver best-in-class Quality Assurance, ensuring compliance and supporting clinical study leading to market approvals so that together, we can improve lives through transformative clinical research.
Our Quality Assurance team has the right knowledge and in-depth expertise to ensure effective quality oversight and help you navigate global regulations and compliance requirements.
We adhere to ICH-GCP, GCLP, ALCOA+, 21 CFR Part 11, ISO 15189, ISO 17025 and GAMP-V standards and applicable regulatory requirements and guidance in the regions where we deliver services, ensuring compliance with local regulations, by leveraging local expertise and taking a risk-based approach.
All our team members are trained on quality and regulatory compliance and standard operating procedures that also anticipate and comply with regional or local regulatory requirements and our robust, harmonized Quality Management System (QMS) means we can assure you that everyone on your project team has been trained to meet the same high standards.
Our deeply experienced, QA team, have extensive past experience in strategically preparing for, hosting, managing and closing out regulatory inspections for our clients, supporting dozens of client audits annually with minimal to no findings including inspections from various regulatory bodies where we work, such as MHRA, HC, USFDA, NDCT 2019, NPRA, WHO, ROW among others.
Robust Quality Assurance:
• Full audit program of internal and external audits
• Hosting and close out of inspections
• Regular Executive leadership review and feedback on the QMS effectiveness
• Vendor Qualification
• Ensuring Inspection and Audit-readiness, through staff training
• Development, maintenance of robust Quality Management system, standards, SOPs, staff training and metrics
• Regulatory authority inspection support
• Gxp system risk assessment, validation, change control/management and periodic review
• Documentation review
• GxP investigations/deviation reports/Quality Event/CAPA system
• Training