GLP- / GCP-Compliant Analytical Testing 

Dedicated GLP / GCP laboratories separated from the non-GLP laboratory space

Established quality management system compliant with the OECD principles of GLP and with the ICH guideline for GCP

Storage stability testing of test items in biological matrix / of study samples

Method validations in conformance with the

  • EMA Guideline on bioanalytical method validation
  • US FDA Guidance for Industry for Bioanalytical Method Validation

QA unit performing:

  • Document and data audits on each study
  • Inspections (process- & facility-based inspection program)

GLP-certified test site

Segregation of critical activities preventing cross-contamination

Documented chain of custody from receipt of study samples until disposal

Established change control and CAPA procedures

PK and TK analyses of study samples from GLP-tox studies and from clinical trials:

  • Unique and proprietary assay system for the sensitive detection of oligonucleotides
  • Quantigene branched DNA assay for the quantitative detection of mRNA