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Ground Zero Pharmaceuticals Announces Expansion of Regulatory and Product Development Consulting Services
Date:10/15/2008

IRVINE, Calif., Oct. 15 /PRNewswire/ -- The increased emphasis on safety by regulatory agencies worldwide has led to more costly medical product development programs and requires rapid, cost-effective and resource intensive actions by Sponsors to respond appropriately. Expertise to effect constructive change can be found in consulting organizations. GZP has already emplaced systems to protect our clients from compliance errors that can lead to adverse regulatory action by the FDA. Throughout the product lifecycle, better use of resources by small and medium sized firms and wise allocation of funding can lead to more success with the FDA review process.

In 2008 GZP dramatically increased the number of US, Australian, and Asian clients (including its first Japanese and Hong Kong firms). Programs that it represents to the FDA range from mid-discovery through full-scale clinical, marketing application submission, and post-approval. This includes bioterrorism and nuclear warfare-related initiatives through the US government's Project Bioshield/BARDA programs.

Several INDs that GZP created and submitted in 2007/2008 received a first-cycle clearance to proceed with clinical trials. Throughout its almost ten year history GZP has had a first-cycle success rate of more than 90%. A number of pre-pre-IND, pre-IND, end of Phase 1 and end of Phase 2 meetings with the FDA led to successful acceleration of drug and biologic development programs for our clients. The firm expects additional programs to be initiated in the fourth quarter of 2008 and throughout 2009.

According to Evan Siegel, "The addition of high quality technical Team Members, with an average of more than 20 years' experience, combined with zero turnover of our people, allow us to continue the excellent service we have always provided our clients. We continue to benefit from their loyalty, referrals, and expansion into new therapeutic areas by maintaining the continuity of trust that is so
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SOURCE Ground Zero Pharmaceuticals, Inc.
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