Regulatory Compliance
Pure Solutions state of the art facility dedicated to clinical trial sterile filling, low bioburden manufacturing, and microbiological testing, offers world class and first in Australia qualified isolator technology for sterile fill and microbiological testing operations.
Our facility operates in adherence to high-quality cGMP standards and TGA standards are designed to deliver products to international compliance standards, ensuring patient safety.
Pure Solutions operates in a fully cGMP-compliant environment and is subject to rigorous regulatory oversight. Our facility has been inspected and accredited by:
Therapeutic Goods Administration (TGA)
Australian Pesticides and Veterinary Medicines Authority (APVMA)
Victorian Department of Health and Human Services
Department of Health and Aged Care: Office of the Gene Technology Regulator
Department of Agriculture Fisheries and Forestry
Granted licences
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Facility Establishment Number FEI: 3032823828
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In addition, we hold the following licences: