our quality system
Our quality system is constantly evolving and is designed to adapt to the various regulations and standards applying to Advanced Therapy Medicinal Products (ATMPs). It ensures compliance with regulations within the whole scope of GenoSafe’s activities.
GenoSafe is an expert in the development and validation of analytical methods for ATMPs
Methods are validated in accordance with current regulatory requirements (ICH, European and national regulations) and applicable criteria:
Specificity (identification and impurity) / Accuracy / Precision (repeatability, reproducibility, intermediate precision) / LoD (Limit of detection) / LoQ (Limit of Quantitation) / Linearity / Range / Robustness
An integrated quality system, GxP compliant and deployed in all our fields of activity
GenoSafe is certified “Good Laboratory Practices” (GLP) since 2008. GenoSafe applies the “Good Clinical Practices” (GCP) and “Good Manufacturing Practices” (GMP) standards and works constantly to maintain the certifications required for its activities.