Quality Assurance

Histologix as a GLP/GCP accredited company is compliant with all the relevant guidelines associated with undertaking regulatory preclinical safety assessments which are likely to form part of regulatory submissions as well as the handling, of patient samples from clinical trials.

Histologix’ quality assurance programme is mainly processed based for which we undergo quarterly internal QA audits, however we also undertake study specific audits on request.

The MHRA inspect Histologix at 2 yearly intervals with the initial inspection being held in 2005 where accreditation was granted and this was retained following subsequent inspection in 2007, 2010, 2012, 2015 and 2016.

Immunohistochemistry

Antibodies intended for therapeutic clinical use must undergo screening in human tissue as part of any regulatory preclinical safety assessment.

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