Accreditation and Compliance

• cGMP inspection by the FDA (No Action Indicated)
• Full OECD GLP Compliance (AFSSAPS, ANSE (AFSSA), GIPC)
• Full Eudralex GMP Compliance (AFSSAPS Authorization Nos. M07/258, ANSE (AFSSA) and V2578/07, FDA Registration No. 3006118993)
• ISO 14001 certification (Environmental Management System)
• Accreditation from DDPP for in vivo experimentation
• Accreditation to carry out radiolabelled studies (³H, ¹⁴C, ³⁵S compounds) from 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)