Precision to the last detail

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)
  • Animal Welfare (incl. AAALAC)
  • GCLP
  • 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)
  • GDP
  • GVP
  • GAMP 5 (CSV)
  • ISO 14155 (medical devices)
  • ISO 13485 (in vitro diagnostics)
  • ISO 9001 (all clinical research areas)
  • EU/EMA/WHO standards
  • National regulatory requirements