GMP Manufacturing

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.

GMP Manufacturing

 

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.

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.   HiTech Health is a full-service Contract Development and Manufacturing...

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