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.
Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland
HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O'Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy...
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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