Audits of CDMOs and Contract Testing Laboratories
Using our expert technical and quality auditors, HiTech Health can perform due diligence and compliance audits of your key manufacturer, supplier or contract testing service to EU/FDA GMP standards.
Compliance Audits and Technical Transfer
A cornerstone of HiTech Health is our GMP experience and expertise in GMP regulations, specifically in CGT products. Ensuring that your CDMO or key contract testing laboratories are at the standard required for product approval is critical. HiTech Health can perform audits to assess the GMP compliance of your contractors and can work with your contracted partners to implement effective remediation and corrective and preventative actions to ensure CDMOs operate optimally and to client expectations.
EU and US Site Audits
Our flexible team can travel to your CDMO/Contract testing laboratory sites and conduct due diligence and compliance audits to both EU and FDA GMP standards.
HiTech Health awarded with €7m government funding for 'disruptive' project HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...
HiTech Health and blood cancer charity Anthony Nolan have entered into an agreement to facilitate the development of novel cell and gene therapies. Anthony Nolan Cell & Gene Therapy Services will support HiTech Health’s supply chain through the provision of a...
HiTech Health, SextonBio and MedInstitute announce collaboration to develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation systems. Sexton Biotechnologies, in partnership with HiTech Health and Med...
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