IRVINE, Calif., Oct. 7 /PRNewswire/ -- Developers of safe and effective pharmaceuticals, biologics, medical devices and biotechnology products are in a highly competitive environment. Integrated, cost-conscious planning and execution of development programs can lead to FDA approval and marketing in a shorter time. The key is the proper application of regulatory knowledge and blending of preclinical, clinical and manufacturing data in working with FDA Reviewing Divisions, assuring quality submissions and negotiating the best arrangement for facilitated review.
Ground Zero Pharmaceuticals, Inc. (GZP), a regulatory affairs and product development consulting company, has tapped the opportunity to bring on additional expertise in the clinical development, data management, study monitoring and biostatistics areas. Working seamlessly with experienced clinical CROs, the firm can now provide sophisticated regulatory and medical strategy, pharmacokinetic/pharmacodynamic study planning, toxicological analysis, review of chemistry, manufacturing and controls data and clinical trials conduct for medical products in the US and abroad. This increases the impact on client programs through the application of a broad body of knowledge and experience, from discovery through post-approval. GZP has also augmented its capabilities in providing review and advice on medical device Quality Systems and GMP manufacture of clinical trial material and commercialized products, both small molecules and therapeutic proteins, including monoclonal antibodies.
Over the last year GZP has dramatically increased the number of European, Australian and US firms and programs that it represents to the FDA, and has expanded into New Zealand, acting as a bridge between early discovery and development work through full-scale clinical development of products under regulatory review.
According to Evan Siegel, Ph.D., President and Chief Executive Officer, "The expansion of our work into full-scale clinical research has enabled us to begin fulfilling the needs of firms to efficiently outsource their programs to one experienced provider of services, while maintaining the same quality, client-centered philosophy, straightforward and efficient approach from which we have built our reputation over many years. We continue to feel that our understanding approach to the basic sciences and intellectual property upon which development programs are built, melded with practical clinical development strategy and the realistic needs of FDA is critical for a continuous flow of new and important therapies into the US marketplace. Consideration of, and preparation for, key pre-IND consultations, strategic preclinical programs, and the important Phase 1/2 and Phase 2/3 decision points can allow Sponsors to retain their aggressive but logically-based timelines in a manner that conserves resources, time and funding. Successful regulatory interactions that move the research and approval processes forward can be aided immeasurably with the help of an experienced development partner and consulting firm such as Ground Zero Pharmaceuticals."
In related developments, Dr. Chaline Brown has been promoted to the position of Senior Manager of Clinical Affairs, responsible for our clinical pharmacology and clinical operations. Dr. Brown has been with GZP since shortly after its founding in 1999. In addition, Ms. Michele Smith has been promoted to the position of Manager of Administrative Affairs. Ms. Smith has been with GZP since 2002.
Based in Irvine, a major center of pharmaceutical and 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, strategic medical strategy, preclinical planning and data assessment, medical writing, manufacturing controls analysis, clinical assessment, data management, clinical monitoring, biostatics, and project management.
The GZP Core team is located in various locations across California; the Research Triangle Park, North Carolina; Houston and Austin, Texas, Washington, DC; Phoenix, Arizona; Orlando, Florida; British Columbia, Canada; Brisbane, Australia; and Malmo, Sweden.
For further information please contact Evan B. Siegel, Ph.D., of Ground Zero Pharmaceuticals, Inc., +1-949-852-3666, fax, +1-949-852-3655, info@groundzerous.com, http://www.groundzerous.com/.
Ground Zero Pharmaceuticals, Inc.CONTACT: Evan B. Siegel, Ph.D., of Ground Zero Pharmaceuticals, Inc.,+1-949-852-3666, fax +1-949-852-3655, info@groundzerous.com
Web site: http://www.groundzerous.com/
