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.
![julie-ann-oneill-web](https://hitech-health.com/wp-content/uploads/2020/10/julie-ann-oneill-web-e1602320072230.jpg)
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.
![Site-Audit_HiTech_Health_web](https://hitech-health.com/wp-content/uploads/2020/10/Site-Audit_HiTech_Health_web.jpg)
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.
GMP Manufacturer for Sterile Formulations including Cell and Gene Therapies
Ireland, 12th Feb 2024: Hitech Health, a Contract Development and Manufacturing Organisation (CDMO) for advanced therapies, has opened an additional facility in County Galway, Ireland. The new high-specification manufacturing centre is equipped with state-of-the-art...
2023 ATMP Review
The Advanced Therapeutic Medicinal Products (ATMPs) sector is evolving rapidly and new products have already demonstrated the ability to reverse or significantly impact the progression of disease. In recent years, the advent of cell and gene therapies has shown the...
Cell Therapies: HiTech Health & VascVersa Partnership
HiTech Health is thrilled to announce its partnership with VascVersa, a trailblazer in regenerative medicine focusing on pioneering cell therapies that significantly enhance vascular regeneration and repair. Originating from Queen's University Belfast, VascVersa is a...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.