Augments staff in regulatory, non-clinical and biologics chemistry, manufacturing and controls areas
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Ground Zero Pharma (GZP) has opened a new office in downtown Brisbane, Australia in July, to better support an expanding Australian clientele in taking their programs to the FDA. The company is now adding Australia-based associates with FDA, TGA and EMEA experience to increase access to its expertise in regulatory-based medical product development and the local client’s ability to meet conveniently with their staff.
GZP also augmented its staff in the regulatory, nonclinical, and biologics chemistry, manufacturing and controls areas to further serve its clients.
Through constant communication with the FDA in the form of pre-pre-IND, pre-IND, and mid-phase meetings with the FDA, the company received first-cycle clearance to proceed with clinical trials for INDs submitted in 2008 and 2009.
Ground Zero Pharmaceuticals is an Irvine, South-California-based biotechnology center, providing strategic and tactical consulting support in regulatory affairs and product development to pharmaceutical, biotechnology and medical device industries.
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