GXP Engaged Auditing Standards

Services related to the following GXP areas:

• GCP (Good Clinical Practice as defined by the European Directives 65/65/EEC, 75/318/EEC, 2001/20/EC and 2005/28/EC)
• GLP (Good Laboratory Practice as defined by the DIN EN ISO 15189 and DIN EN ISO/IEC 17011)
• GMP (Good Manufacturing Practice as defined by the European Directive 2001/83/EG, 2005/28/EC , the EU GMP Guideline, Annex 13 and the EudraLex Vol. 10 Clinical Trial Guidelines - Quality of the Investigational Product - guidance on IMPs and other medicinal products used in clinical trials)
• ISO 9001 (all clinical research areas)
• ISO 14155 (medical devices)
• ISO 13485 (in-vitro diagnostics)
• Pharmacovigilance (EudraLex Volume 9A, ICH and national regulations)
• FDA standards
• EMA standards
• WHO standards
• National regulatory requirements