IRVINE, Calif., Oct. 6 /PRNewswire/ -- A major increase in innovative concepts for exciting therapeutic and preventive new products in Australia has led to an expansion of GZP's activities Down Under, to better support clients in their efforts to take their programs to the US Food and Drug Administration. Our new office in downtown Brisbane, Australia was established on July 1 and we are adding Australia-based associates with FDA, TGA and EMEA experience to expand access to our worldwide expertise in regulatory-based medical product development and increase our local client's ability to meet conveniently with our staff .
Current activities in Australia include speaking engagements for Dr. Evan Siegel at the following venues in October:
21/10/2009 - Adelaide - 2009 National Preclinical Seminar Series - "Getting to the IND"
28/10/2009 - Melbourne - AusBiotech 2009 - "Global Regulatory Challenges and Opportunities"
Internationally, GZP continues to believe that early and frequent communication with the FDA as the key regulatory agency can lead to accelerated product development, better use of resources, and more funding.
In 2009, despite a difficult climate, GZP increased the number of US, Australian, and European clients with US FDA programs both early and late in development in the indications of oncology, infectious disease, cardiovascular medicine, neurological disease and immune function disorders.
INDs created and submitted in 2008/2009 received first-cycle clearance to proceed with clinical trials. Pre-pre-IND, pre-IND and mid-phase meetings with the FDA led to rapid movement of drug and biologic development programs for our clients.
According to Evan Siegel, "We continue to benefit from the loyalty of our clients, their referrals, and expansion into new regions, by continuing to uphold our core principles of exceptional quality staff, generation of creative, high-value deliverables, and enhanced strategic planning."
In related developments, GZP has augmented its staff in the Regulatory, Nonclinical, and biologics Chemistry, Manufacturing and Controls areas to further serve its clients.
Based in Irvine, a major biotechnology center in Southern California, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs and product development consulting firm providing strategic and tactical support to the pharmaceutical, biotechnology and medical device industries. Its services include regulatory representation and submissions (paper and electronic), strategic medical consulting, preclinical planning, auditing and review of clinical, nonclinical and CMO sites, medical writing, chemistry, manufacturing and controls consulting, clinical assessment, data management, biostatics, and project management. GZP has strategic resources, throughout the US, Canada, Australia and Europe, and a wholly owned subsidiary in Brisbane and Melbourne, Australia.
For further information please contact Ms. Tisha Templeton, Senior Vice President of Finance and Operations, Ground Zero Pharmaceuticals, Inc., +1-949-852-3666, fax, +1-949-852-3655,