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.
Overview On the 24th December 2020, a Trade and Cooperation Agreement (TCA) was struck between the EU and UK. This is welcomed by the pharmaceutical industry as it helps with maintaining continuity of supply and flow of medicinal products as well as other products...
EU Market Access for UK Companies The UK life sciences industry contributes over £30 billion to the UK economy, and supports almost half a million UK jobs. The UK is a leading centre of medical research and biopharmaceutical innovation and is at the forefront of drug...
We are pleased to officially announce the launch of our new website, which reflects our expanding role as a leading professional service provider to pharmaceutical, biotechnology and medical device companies. We are highlighting our services for Advanced...
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