Ground Zero Pharma expands regulatory consulting services
services it offers enabling the expansion into more of its clients'
late-stage development programs, with the potential for creating
submissions that lead to FDA approval.
GZP aims to address the increase in costs and safety concerns raised by physicians and regulatory agencies. Indeed, the landscape of new drugs, biologicals and combinations with medical devices has resulted in more organised, effective and proactive medical product programs that have lead to fewer failed products while expediting FDA approval. In this latest announcement, the company have added additional expertise in clinical protocol development, study auditing and pharmacogenomics to the range of services it has already built up. GZP's services extend into therapeutic areas such as cancers, AIDS, antiinfectives and antivirals, cardiovascular conditions, emergency plasma volume expansion, and serious neurological disorders such as Stroke, Peripheral Arterial Occlusion, Parkinson's disease, and Alzheimer's disease. "The in-depth expertise that we have always had at GZP, enhanced by our new resources, brings us additional satisfaction as we see the end result of these programs, some of which we have helped develop from their earliest stages," said Evan Siegel, President and Chief Executive Officer. "We have worked with several of our clients for many years and believe that the most effective outsourcing relationships are those based on quality and trust, with the inevitable facilitative working relationships and cost savings fostered by long-term commitment on both sides." In 2006 GZP increased the number of Australian and US firms and programs that it represents to the FDA, for early discovery through full-scale clinical development and approval. So far, an office has been opened in Melbourne, Australia to accommodate a wholly owned subsidiary, Ground Zero Pharmaceuticals Pty Ltd., established in October 2006 to better service its clients in that region. An NDA that GZP created and submitted in 2005 received a first-cycle approval in May 2006. The firm is under contract for two electronic (eCTD) BLAs and an electronic (eCTD) NDA and expects additional such programs to be initiated in 2007.
