Extensive experience in end-to-end management of clinical trial supply. Coordination with CMC, Clinical, DM, QA/QP, and CMO/third-party depots.
GxP System Validation
Computer system and equipment validation framework to ensure compliance with current EMA and ISPE guidelines, and in line with your QMS system.
System Vendor Selection
Requirement specification and vendor selection projects of GxP systems and outsourcing of GMP/GDP activities.
Executes your QMS and SOP writing projects with broad experience in best practices from leading pharmaceutical and biotech companies.