EU QP Services
Our Qualified Persons (QPs) can offer expert quality support to your company to successfully release your product to clinical trials or to market in both EU, UK, and RoW.
QP and Quality Services
HiTech Health provides contract QP services, for both general Quality consultancy and batch release, for short and long-term contracts.
Our QPs and quality team can support you through:
- Obtaining and maintaining Quality Management System (QMS) compliance.
- Designing and implementing robust supplier qualification and management process.
- Creating and delivering effective GMP training courses.
Importation and QP Certification
HiTech Health holds Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU.
By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market.
Cell and Gene Therapies: 3 Key Supply Considerations
Personalised medicines involve an increased degree of complexity when it comes to manufacturing and supply in comparison to traditional pharmaceuticals. The Horizon 2020 Advisory Group defines personalised medicine as 'a medical model using the characterisation of...
EMA Regulation of Cell and Gene Therapies (CGTs)
Cell and Gene Therapy products and other Advanced Therapy Medicinal Products (ATMPs) have to comply with European Medicines Agency (EMA) legislation at different stages of the development process, including Good clinical practice (GCP), Good manufacturing practice...
Cell and Gene at the Abbey 2021 – Galway, Ireland
From 10th to 12th November, HiTech Health hosted ‘Cell and Gene at the Abbey’, a world-leading conference focusing on Production, Scale-up and Globalisation of cell and gene therapies. We would like to sincerely thank all the speakers, sponsors and attendees of this...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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