The pillars of our quality management system to support your drug studies are:

  • GCLP*-compliance of all procedures carried out in our service laboratory
  • Highly trained, skilled and experienced personnel
  • Highest patient safety by consistent sample management and maximum data integrity
  • Extensive assay validation and peer-review for all (experimental) procedures
  • GxP compliant documentation from sample receipt via reporting and data transfer to archiving
  • Application of validated computerized systems
  • Internal quality assurance by regular monitoring of all laboratory procedures (SOPs) by QA personnel
  • Implemented risk management
  • Change and deviation management (CAPA)
  • Open, efficient and solution-oriented communication with our customers

* European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.” EMA/INS/GCP/532137/2010, GCP Inspectors Working Group Adoption July 28, 2012.

 

 

 

Good Clinical Laboratory Practice (GCLP)