Cryosite’s purpose-built, modern facility 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 is highly experienced in working with regulatory and statutory authorities. Combined with our deep knowledge of the clinical trial cycle, we are adept in guiding clients through the processes required for permits and licenses.
Cryosite’s quality management embraces the key systems of quality assurance and quality control. Quality control is an integral part of our daily operations to ensure quality requirements are fulfilled for each part of the clinical trial logistics process. In turn, our quality assurance provides you with confidence in our quality control by documenting compliance with protocols, Good Clinical Practice and relevant regulatory requirements.
Regular internal and external audits of our quality management systems are performed. In turn, our quality management systems provide full audit reporting to national and international pharmaceutical companies and CROs.
Cryosite uses cutting-edge technology to maintain the safety of stored products in our secure and fully monitored facility.
Secure electronic access ensures only authorised persons are permitted into areas where products are stored. The facility has 24/7 surveillance and security, with internal and external systems.
