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.
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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