Quality Assurance
Synergen Bio is committed to deliver quality and regulatory compliant clinical trial services in a professional, efficient, timely and cost-effective manner while protecting patient safety and data integrity for regulatory submissions.
Synergen Bio offers the Quality Assurance (QA) services in GCP domains in line with applicable GxP regulations. Quality assurance auditors have expertise in local, national and international regulations, standards and guidelines.
Key Strengths:
- Independent quality assurance function reporting to management for all in-house Clinical and Bioanalytical studies.
- Well structured QA audits at pre-defined intervals to ensure data integrity
- Regular system audits to facilitate continuous system improvements
- Handle regulatory/sponsors queries, recommendations through corrective/preventive actions, modifying and implementing our systems and processes wherever required
- Conduct internal audits of study activities and data/reports and ensuring compliance as indicated by acceptance of the product dossiers (Regulatory submissions) by regulatory agencies
- Manage sponsor audits for assessment of Synergen Bio facilities & GCP/GLP compliance
- Dedicated, qualified & well trained QA auditors
- Teams with well defined job responsibilities for conducting internal audits, document control and archival activities
- Fire proof and access controlled Archival facility which is situated within QA department.