Qualified Persons (QPs) Specialising in CGT

HiTech Health has QPs with expert knowledge in the CGT and ATMP field and can offer quality support for the successful release of your CGT product.

Cell & Gene Therapy QP Services

 

In Europe, no batch of medicinal product can be released prior to certification by a Qualified Persons (QP). Due to the rapidly evolving ATMP landscape it is key to have up-to-date knowledge and expertise to successfully release product to clinical trials. HiTech Health’s QP team have the sought-after experience required to manage Quality aspects of product and process development.

HiTech Health Qualified Person (QP) batch release is in accordance with EU requirements (article 13 of EC Directive 2001/20/EC) on Investigational Medicinal Products (IMP) covering both sterile and non- sterile various dosage forms, including Advanced Therapeutic Medicinal Products. With HiTech Health’s clinical IMP MIA in place, CGT products can be imported and released to EU clinical trials in a matter of months.

EU Market Access for UK Companies

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...

HiTech Health Launch New Website

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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