Agilex Biolabs Pty Ltd

Site

Bio-analytical Laboratory

Accreditation No.

15130

Site No.

15629

Date of Accreditation

01 Nov 2004

Address

28 Dalgleish Street
Thebarton, SA 5031
Australia

agilexbiolabs.com

Contact

Mr Jason Valentine P: +61 (08) 83028733

Availability

Services available to external clients

Scope of Accreditation

Bio-analytical Laboratory

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique
Analysis in support of clinical trials and/or pre-clinical studies Animal biological samples; Human biological samples Biomarker parameters; Immunogenicity parameters; Pharmacodynamics (PD) parameters; Pharmacokinetic (PK) parameters; Specialised pharmacodynamic studies Enzyme linked immunosorbent assay (ELISA) - Immunoassay; LC-MS-MS

Capability

Methods validated to FDA and EMA bioanalytical method validation guidances and/or industry consensus white papers.

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.