Quality management

Quality Assurance is one of Aepodia’s pillars. We have worked hard to set up a robust quality system ensuring compliance with ICH-GCP and country regulations. Ensuring excellence in everyday service to our customers, we continuously maintain, check, and improve our quality system. We benefit from a well-trained and experienced quality team, always attentive of the evolving quality environment. The system is flexible to accommodate any type of collaboration with clients through Individual Project Agreements, RACI definitions, and Operations Guides.

We set up our own files for Standard Operating Procedures, which have been developed in compliance with ICH-GCP and are used to conduct our activities, when needed.

Study files are maintained based on an "Inspection-Ready" philosophy.

EMA (European Medicines Agency)
FDA (US Food and Drug Administration)
ICH (International Conference on Harmonisation)