Quality Assurance
Quality Assurance Services
Quality, trust and data integrity defines our approach to every step of drug development programs. We are committed to providing high-quality, safe and effective products and services. Pharmaron’s quality assurance specialists are involved in all parts of the business, providing QA support to project teams and clients.
Our team conducts regular internal audits to ensure that the GMP standards are controlled and maintained throughout the drug product development and manufacturing life cycle.
Capabilities
Quality Management System
- Follows ICH Quality Guidelines and in alignment with current Good Manufacturing Practices (cGMP) and global regulatory requirements adopted by the US FDA, NMPA, MHRA, and EMA
- Numerous quality audits completed from regulatory authorities, big pharma and biotech companies in the US, EU and Asia
QA Support Services
- Audit support for clients and assistance with site inspections
- Internal support for project teams and ongoing training programs for all employees to ensure policies, SOPs and work instructions are appropriately implemented and executed
- Internal audits to ensure quality standards are maintained
- Continuous quality improvement, from project development, API and drug product manufacturing to IND/NDA submission and all other areas of our business
