QA/RA

Pharmaron’s quality system has passed numerous quality audits from big pharma and biotech companies and is in compliance with regulatory requirements. Our GMP API and drug product manufacturing facility is qualified for manufacturing GMP API and drug product to support clinical trials worldwide.

• Quality assurance system follows ICH Quality Guidelines and supports API and drug product development and manufacturing in compliance with US FDA, NMPA and EMA for all cGMP requirements
• Regulatory support preparation for full data packages and documentation for regulatory filing
• Numerous GMP audits by clients in US, EU and Asia

Learn more about Pharmaron's Regulatory Affairs services