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 central to our industry. We believe that using sophisticated strategic, tactical regulatory experience and intelligence to medical product development from the very beginning will always benefit the generation and integration of technical data into efficient, viable development programs."
In related developments, GZP has augmented its staff in the Regulatory and scientific areas to further improve its efficiency in handling the increased workload attendant to the growth of both its client base and new programs from existing clients. This includes the addition of Anthony Shaw and Greg Coulter with expertise in Chemistry, Manufacturing and Controls, both of whom began working with GZP clients in 2007/2008. In addition, Dr. Terrence Chew, board certified in internal medicine and an oncologist, has begun strategic medical consulting to GZP clients, including providing Medical Monitoring services for Clinical Studies. Evan Siegel, Ph.D., President and Chief Executive Officer, lectures as an Adjunct Professor at the University of Queensland in Brisbane, Australia. GZP, at its Irvine, California offices, hosted its first regulatory interns from the School of Pharmacy and Biotechnology programs from the University of Queensland.
Based in Irvine, a major center of biotechnology innovation in Southern California, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs and product development consulting firm providing strategic and tactical support to the pharmaceutical, biologics, biotechnology and medical device industries. Its service portfolio includes 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 uses strategically identified resources, throughout the US, Canada, Australia and Europe, and has a wholly owned subsidiary in Melbourne, Australia.
For further information please contact Ms. Tisha Templeton, Vice President of Finance and Operations, Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, fax, +1-949-861-9797, firstname.lastname@example.org.
Web Site: http://www.groundzerous.com
CONTACT: Tisha Templeton, Vice President of Finance and Operations of
Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, fax, +1-949-861-9797,
Web site: http://www.groundzerous.com/