Quality Assurance
Synergen Bio is committed to delivering high-quality, regulatory-compliant clinical trial services in a professional, efficient, timely, and cost-effective manner, while ensuring patient safety and maintaining data integrity for regulatory submissions.
Our Quality Assurance (QA) services in the GCP domain are aligned with applicable GxP regulations. Our QA auditors possess extensive expertise in local, national, and international regulations, standards, and guidelines.
Key Strengths:
- Independent Quality Assurance Team reporting directly to management for all in-house Clinical and Bioanalytical studies
- Well-structured QA audits at predefined intervals to ensure data integrity
- Regular system audits to support continuous process improvement
- Effective handling of regulatory and sponsor queries/recommendations through corrective and preventive actions, with system and process updates as required
- Comprehensive internal audits of study activities, data, and reports, ensuring compliance reflected by the acceptance of product dossiers (regulatory submissions) by global agencies
- Management of sponsor audits to assess Synergen Bio’s facilities and GCP/GLP compliance
- Dedicated, qualified, and well-trained QA auditors
- Clearly defined team responsibilities for internal audits, document control, and archival activities