GMP Manufacturing
We can provide a full GMP manufacturing service for Sterile Formulations and Advanced Therapies, including cell and gene therapies. Our team provide quality and compliance services including QP release of products.
GMP Manufacturing
Our GMP facilities (EU GMP Approved) are specifically designed to manufacture sterile formulations and advanced therapies, providing you with end-to-end development and manufacturing services. the range of services include sourcing and supply of starting materials for products ,offer GMP manufacturing, QC analytical and microbiological testing including rapid safety test methods (Sterility, Endotoxin and Mycoplasma) and the development of potency and release assays. Designing and performing stability studies, which are critical for product development and filing, are also available at the site. In addition we offer batch approval using our own Qualified Personnel (QP’s) for both the EU and UK.
We can support our clients with material importation and shipping of products. This includes cryogenic, cold chain and ambient shipments.
We also support our clients with regulatory documentation preparation, such asthe Investigational Medicinal Product Dossier (IMPD) and CT Protocol.
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
Cell Therapy: Points to Consider When Choosing a CDMO
At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With...
Accelerating Regenerative Medicine : CCRM Australia and HiTech Health Announce Strategic Partnership
Hitech Health is delighted to announce its latest partnership with CCRM Australia, a not-for-profit organisation supporting regenerative medicine commercialisation in the Australian market. CCRM Australia works to accelerate the commercialisation of regenerative...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.