QUALITY / COMPLIANCE
Focus on high quality and uncompromising compliance guarantee you trusted answers
Unilabs has an experienced in-house independent Quality Assurance (QA) group.
The Unilabs Quality Management System will ensure that your project will be performed and reported in accordance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, and ISO/IEC 17025:2005, ISO 15189:2012 as applicable.
Unilabs is regularly subjected to audits by Sponsors and regulatory authorities.
Confidence in your data/results is guaranteed by high quality and compliance levels.
GMO class I Laboratory
Unilabs GMO class I facilities are licensed by the Danish Working Environment Authorities. Special regulations apply when working with genetically modified organisms (GMOs) such as vector transferred genes (gene therapy) considered for clinical treatment.
Isotope class C Laboratory
Unilabs Copenhagen is licensed by The Danish Working Environment Authority for Radioimmunoassay (RIA). Unilabs has more than 30 years’ experience in the development and validation of RIA methods. Although RIA has now largely been replaced by non-isotopic methods (primarily ELISA), it remains the method of choice for some analyses where other methods fail to provide the necessary specificity or sensitivity. Unilabs have maintained the necessary facilities and expertise to provide continued support for both RIA assays (RIA/IRMA/radioreceptor assay).
Biosafety Level II Laboratory
Unilabs Copenhagen is equipped with Biosafety Level II facilities licensed by The Danish Working Environment Authority. Laboratory work with biological agents such as viruses and bacteria requires special precautions and licensing. Biocontainment is classified by the relative danger to the surrounding environment as biological safety levels I through IV. At Unilabs Copenhagen we are equipped to work with biological agents within Biosafety levels I and II.