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.
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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