We can provide a full GMP manufacturing service for Advanced Therapeutic Medicinal Products (ATMPs) and offer quality and compliance services including QP release of products.
Our facilities are specifically designed to manufacture ATMPs where we can offer start to end manufacturing services. We can supply starting materials for ATMPS and offer manufacture, analytical and microbiological testing including rapid test methods and development of potency and other release assays. In addition we offer batch approval using our own Qualified Personnel (QP’s).
We can support our clients with material importation and shipping of quality samples as well as final product. This includes cold chain shipping of product.
We also support our clients with data preparation for use in their Investigational Medicinal Product Dossier (IMPD) regulatory filings.
Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland
HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O'Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy...
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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