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Ground Zero Pharmaceuticals Announces Expansion of Regulatory Consulting Services to South Africa
Date:10/9/2007

IRVINE, Calif., Oct. 9 /PRNewswire/ -- The advent of biosimilar drugs, new combinations of old ingredients and clinical trial failures in Phase 3 have required new emphasis on "doing it right, the first time." Better use of resources, carefully selected outsource partners and wise allocation of funding lead to fewer failed products in late stages and more success with the FDA review process.

In 2007 GZP added its first South African clients while dramatically increasing the number of Australian and US firms and programs that it represents to the FDA, for mid-discovery through full-scale clinical development and approval.

Several INDs that GZP created and submitted in 2006 received a first-cycle clearance to proceed with clinical trials. A number of pre-IND and end of Phase 2 meetings with the FDA led to successful acceleration of drug and biologic development programs for our clients. Special Protocol Assessments (SPAs) for Phase 3 programs have been submitted and successfully negotiated with the Agency, as well as Orphan Drug and Fast Track status requests. The firm is under contract for two electronic (eCTD) BLAs and three eCTD NDAs and expects additional such programs to be initiated in 2008.

According to Evan Siegel, Ph.D., President and Chief Executive Officer, "The additional resources, combined with zero turnover of our people, allow us to preserve continuity with our long-term clients and to offer the same level of expertise, commitment and rapid turnaround to our new clients. We continue to enjoy the privilege of working with new additions to drug and biologic pipelines while bringing our more than 400 aggregate years' experience in medical product development to bear on the programs of firms new to our partnership. We believe more than ever that bringing regulatory excellence to the table at the beginning of a program, combined with efficient and knowledgeable project management and technical expertise in all disciplines, can launc
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SOURCE Ground Zero Pharmaceuticals, Inc.
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