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.
New FDA ‘Super Office’ created for Cell and Gene Therapy Products
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Importation of Medicinal Products: Understanding the EU requirements
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
PMTC Spotlight – HiTech Health
HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight. HiTech Health is a full-service Contract Development and Manufacturing...
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