Quality and regulatory compliance

 

Quality matters!

High quality standards and processes are essential when working in bioanalytical projects. Our GCP, GLP, and ISO 17025 compliant laboratory is managed and staffed by scientists with significant experience in regulated environments. Moreover, our scientists have long experience meeting guidelines from the EMA and the FDA. 
 

GCP

Wieslab performs bioanalytical testing for clinical drug trials according to ICH E6/RI “Guidance for Good Clinical Practice” 4 June 1996, EU directives 2001/20/EC, and EMA/INS/GCP/532137/2010 Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.
 

GLP

Since May 2015 Wieslab has been part of Swedac´s program of Good Laboratory Practice (GLP) as STAFS 2008:4. Swedac regulations impose OECD principles on the introduction of GLP according to the European Directives 2004/9/EC2004/10/EC and OECD.

Wieslab is GLP approved to perform bioanalytical testing in non-clinical safety studies of drugs (Analytical and Clinical Chemistry Testing).

Click here for the GLP compliance statement by SWEDAC. 
 

ISO/IEC 17025:2005

As a testing laboratory we are compliant, in accordance with the International Standard ISO/IEC 17025:2005, recognized by SWEDAC since 1996. This acknowledgement demonstrates technical competence and the operation of a laboratory quality management system.

Click here for 1502 ISO/IEC 17025 compliance certificate by SWEDAC.