Our Quality Management System (QMS) has been assessed by numerous regulators and pharmaceutical companies for the manufacture and delivery of cell and gene therapies to patients in Australia and the Asia pacific region. We offer robust and flexible quality services to support phase appropriate compliant Good Manufacturing Practice (GMP) manufacturing and delivery of advanced therapies and medicines.
Quality as a Service
Providing Clients With Custom Fit-for-purpose QMS Solutions That Meet Required Regulatory Standards.
License Our Proven Quality Management System
Translatable QMS Solutions For Hospitals, Academic Research Groups And Start-ups
To meet the needs of clients, our Quality Management System can be tailored to be a fit-for-purpose solution that will meet both international and Australian regulatory standards. Our QMS have been implemented in hospitals to support stem cell collections, stem cell transplants, and cell and gene therapy delivery to Australian patients.
ISO Qualifications and Approved Regulations
PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP)
Australian Code of Good Manufacturing Practice for Human Blood, Blood Components, Human tissues and Human cellular therapy products (the Australian Code of Good Manufacturing Practice)
ICH Q10 Pharmaceutical Quality System
ISO 15189, ISO 9001
Australian National Pathology Accreditation Advisory Council (NPAAC)
FDA 21 CFR Part 11
Australian Office of the Gene Technology Regulator (OGTR)
Customized to your program
These capabilities can be provided to clients in need on a fee-for-service basis and is customized to fit the program. Services include gap assessments, external audits, regulatory compliance, quality consulting and expertise, Quality Management System establishment and oversight.
cell therapies is an Australian-based, globally-active commercial contract development and manufacturing company, specializing in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products
Services
Helpful Links
Corporate
Victorian Comprehensive Cancer Centre
Level 9, 305 Grattan Street,
Melbourne, VIC,3000
Australia
+61 3 9492 4777
[email protected]
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