Analytical RnD Pty Ltd

Site

Analytical RnD

Analytical RnD Pty Ltd

Accreditation No.

20683

Site No.

24808

Date of Accreditation

17 Apr 2020

Address

11 Julius Avenue
North Ryde, NSW 2113
Australia

analyticalrnd.com.au

Contact

Dr Rama Nimmagadda P: +61 0412096221

Availability

Services available to external clients

Scope of Accreditation

Analytical RnD

ISO/IEC 17025 (2017)

Agribusiness

Service Product Determinant Technique
Analysis in support of the development and/or optimisation of new assays, devices or techniques Animal feeds; Crops; Food products; Soils; Waters Concentration of pollutant; Concentration of residue LC-MS-MS; LC-UV

Capability

Methods are validated in accordance with the following guidelines: Australian Pesticide and Veterinary Medicine Authority (APVMA) Guidelines for the Validation of Analytical Methods for Active Constituent; Agricultural and Veterinary Chemical Products, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL49(R); National Environment Protection Measure (NEPM) Guideline; Food Standards Australia New Zealand (FSANZ) Guidelines.

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 Concentration of drug and/or biological agents LC-MS-MS; LC-UV

Capability

Projects are managed in accordance with the GCLP Principles interpreted for research.
Analysis in support of the development and/or optimisation of new assays, devices or techniques Human pharmaceutical formulations; Veterinary pharmaceutical formulations Concentration of active ingredients LC-MS-MS; LC-UV

Capability

Methods are validated in accordance with the following guidelines: Food and Drug Administration (FDA) Bioanalytical Method Validation Guidance for Industry; European Medicines Agency (EMA) Guideline on Bioanalytical Method Validation; International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use (ICH) Harmonised Guidelines; Australian Pesticide and Veterinary Medicine Authority (APVMA) Guidelines for the Validation of Analytical Methods for Active Constituent; Agricultural and Veterinary Chemical Products, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL49(R).

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.