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.
Experts in IRT system requirements, operations, and UATs to ensure suitability against study design. Development and execution of system test scripts.
System Vendor Selection
Requirement specification and vendor selection projects of GxP systems and outsourcing of GMP/GDP activities.
Drug Supply Forecasting
SaaS solution provider of a clinical trial supply forecasting tool. An intuitive platform that integrates with all IRT systems.
Executes your QMS and SOP writing projects with broad experience in best practices from leading pharmaceutical and biotech companies.