- Cryosite Limited
- South Granville NSW 2142
- Auburn NSW 2144
Quality-driven processes, validated systems and documented controls designed to support regulated clinical trial and biological operations.
Cryosite’s Ferndell St headquarters is a purpose-built, modern facility which is licensed by the Therapeutic Goods Administration (TGA) of Australia and is Good Manufacturing Practice (GMP) certified to support the specialised needs of highly regulated, temperature-sensitive products.
We take our quality obligations and responsibilities seriously. Cryosite maintains accreditations, has thorough knowledge of regulatory systems and utilises best-in-class management systems to ensure our quality processes.
Cryosite is audited regularly to ensure our storage facilities meet TGA standards.
Cryosite has wholesaler licensing arrangements with NSW Health under the Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8. We ensure a high-quality supply a high-quality supply chain through effective, efficient and safe handling, storage and distribution of medicines.
Cryosite has Department of Agriculture approval to self-manage biosecurity risks and documentation associated with importing clinical trial supplies. We are diligent in maintaining this arrangement through excellence in training, accreditation, monitoring and compliance.
Our systems and equipment are validated and maintained to ensure reliable, consistent performance.
Real-time monitoring with automated alerts helps ensure critical conditions are within specification.
Documented SOPs and ongoing training ensure our team operates to the highest standards.
End-to-end traceability and secure documentation support data integrity and accountability.
We maintain a culture of readiness with regular internal reviews and prepared audit processes.
Our quality systems align with globally recognised standards and regulatory requirements.
Quality is embedded in everything we do. From facility design to daily operations, our systems are built to protect samples, ensure data integrity, and support the success of your clinical trials and biological programs.
Robust processes designed to minimise risk and variability.
Experienced teams applying deep technical and quality knowledge.
Ongoing monitoring and improvement to ensure sustained quality.
Get in touch to discuss how Cryosite can support your clinical trial or research program.
