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.

2023 ATMP Review

The Advanced Therapeutic Medicinal Products (ATMPs) sector is evolving rapidly and new products have already demonstrated the ability to reverse or significantly impact the progression of disease. In recent years, the advent of cell and gene therapies has shown the...

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