Industries We Serve
Medical Device
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ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
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21 CFR Part 820: Quality System Regulation - Medical Devices
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ISO 14971: Medical devices - Application of risk management to medical devices
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TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.
Pharmaceuticals
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21 CFR Part 210 & 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
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Pharmaceutical Ingredients
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ISO 9001: Quality management systems - Requirements
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ICH Q10: Pharmaceutical Quality System
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TGA GMP: Human blood and blood components, human tissues and human cellular therapy products
Contract Manufacturing
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ISO 9001: Quality management systems - Requirements
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21 CFR Part 820: Quality System Regulation - Medical Devices
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ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
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TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.
Tissue Banks
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21 CFR Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products (FDA)
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AATB Standards: American Association of Tissue Banks Standards for Tissue Banking
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TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.
Laboratory Testing
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ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
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21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
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TGA GMP: Human blood and blood components, human tissues and human cellular therapy products
Cold Chain Industry
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ISO 9001: Quality management systems – Requirements
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ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
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TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.