Our quality management system
- Global standards: Both our US and China facilities adhere to strict quality management systems, including ISO 9001, ISO 14001, and cGMP guidelines.
- ICH Q7 compliance: Our processes are aligned with the ICH Q7 guidelines for Active Pharmaceutical Ingredients (APIs).
- FDA registration: Our St. Francis facility is registered with the U.S. FDA, ensuring compliance with US regulations.
- Continuous improvement: We regularly review and update our quality procedures to incorporate the latest industry best practices.
Our quality assurance measures
- Experienced personnel: Our highly trained staff is committed to delivering quality products and services.
- Advanced equipment: We utilize state-of-the-art equipment and analytical instrumentation for precise testing and analysis.
- Robust processes: Our processes include rigorous material management, cross-contamination control, equipment qualification, and maintenance to ensure consistent product quality.
- Thorough documentation: We maintain meticulous records and documentation for complete traceability and accountability.
