Licensing and accreditation
When choosing a company to look after something as precious as your baby’s cord blood stem cells, you need to ensure that the company is properly licensed and accredited and that it is financially secure.
Cryosite’s facility, including its cord blood laboratories and cryogenic storage facility are fully licensed by the Therapeutic Goods Administration (TGA) for the manufacture, storage and release of autologous cord blood stem cells. Importantly,
Cryosite is also independently accredited by Australia’s National Association of Testing Authorities (NATA) to AS ISO 15189:2009. Cryosite’s regulatory licenses and accreditations provide our clients with evidence of independent audit and acknowledgement of the integrity of our systems.
Your decision to store your child’s cord blood is an important one – if you have any questions about the regulatory aspects (or indeed any other aspects) of cord blood banking, please do not hesitate to contact one of our friendly qualified representatives on 1800 220 410.
Cryosite’s licenses
• Therapeutic Goods Administration (TGA): Licence number MI-18072008-LI-002488-11
In Australia, the TGA is responsible for regulating the manufacture of all therapeutic goods. This includes blood, tissues, cellular therapies and cord blood. TGA conducts annual audits of all licensed manufacturing facilities.
• National Association of Testing Authorities (NATA): Accreditation number 14598
Cryosite’s laboratories are accredited to AS ISO 15189:2009. NATA conducts regular audits of accredited laboratories to maintain this accreditation status.
• Australia Quarantine Inspection Service (AQIS): QAP licence number N2115
AQIS is responsible for controlling and regulating the import and distribution of many of the goods that Cryosite manages, including drugs, vaccines and ATCC products. AQIS conducts regular inspections of all quarantine approved premises to maintain this regulatory status.
• NSW Health Department: Licenses 4050 and 0473
For the storage and supply of therapeutic goods. NSW Health performs regular audits of licensed facilities. These licenses are required by Cryosite to provide the storage and distribution of clinical trial drugs.
• International Air Transport Association (IATA)
All relevant Cryosite staff are required to undertake IATA Dangerous Good Regulations training and certification.
• ASX: (ASX code CTE)
As Cryosite is a publically listed company our current and ongoing financial position is also independently audited, is publically available, and complies with the Corporations Act and Accounting Standards & Corporations Regulations. Click for Cryosite Annual Report.