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New FDA ‘Super Office’ created for Cell and Gene Therapy Products
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Importation of Medicinal Products: Understanding the EU requirements
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
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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