Accreditation and Compliance
- Full OECD GLP Compliance (AFSSAPS, AFSSA, GIPC)
- Full Eudralex GMP Compliance (AFSSAPS Authorization Nos. M07/258, AFSSA and V2578/07, FDA Registration No. 3006118993)
- ISO 14001 certification (Environmental Management System)
- Accreditation from French Veterinary Inspection Service (DSV) for in vivo experimentation
- Accreditation to carry out radiolabelled studies (3H, 14C, 35S compounds) from French Authorities (ASN)
- Compliance to ICH and VICH guidelines
QA Activities
- Independent QA unit (10 % of Avogadro’s staff)
- Review of Study Plan, Raw Data, Reports
- Critical phase inspections
- Process inspections
- Annual Quality Assurance Program
Other Activities
- Validation of Computerized Systems (according to 21CFR Part 11)
- Equipment metrology
- Monitoring and maintenance of archives (materials and study documentation)
