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.

Contact Us

Recent News

2023 ATMP Review

Dec 13, 2023 |

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...

Contact Us

Email

info@hitech-health.com

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.