IRVINE, Calif., Nov. 8 /PRNewswire/ -- The climate for pharmaceutical and biotechnology products has changed with increased emphasis on integrated product development, FDA reorganization, and recognition of the need for early markers of safety. Combination products are a major growth area. Strategic global planning and cost-effective development programs can lead to timely FDA approvals. The key is an honest, thorough recognition of early indications of safety issues and efficacy and the proper application of regulatory knowledge to the process. This can reduce unnecessary expenditures of time, funding and scarce resources, particularly for small firms. The accelerated movement toward electronic marketing submissions will aid the regulatory authorities in the review of new products and save time.
Ground Zero Pharmaceuticals, Inc. (GZP), a regulatory affairs and product development consulting firm, is pleased to announce that it has been awarded contracts to prepare fully electronic marketing submissions to the FDA in CTD format as well as the newly required Structured Product Labeling (SPL). The CTD format is acceptable to the EU, Japan, Australia, Canada and other regions as well. GZP has further expanded its core team with expertise in chemistry manufacturing and controls of small molecule drugs and biologics, compliance, preclinical development, clinical protocols, biostatistical analysis, and regulatory affairs in both the US and Europe. Working seamlessly with experienced CROs, the firm provides sophisticated regulatory and medical strategy, medical writing, 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.
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 the UK, India and Taiwan, for early discovery and development work through full-scale clinical development and approvals of products under regulatory review. This has been enhanced with strategic partnerships with firms such as ClinDatrix, Inc. of Irvine, CA, Orion Clinical Research LTD., in London, Integrous Clinical Management Services in Ontario, Canada, and Tetra-Q, PTY in Brisbane, Australia.
According to Evan Siegel, Ph.D., President and Chief Executive Officer, "The expansion of our Core Team and services has enabled us to continue fulfilling the needs of firms to efficiently outsource their programs, including those involving combination products, to one experienced provider, while maintaining the same quality, timeliness, and client-centered approach through which we have built our reputation. We continue to feel that our considerate and flexible approach to the scientific concepts upon which entrepreneurial programs are built, mated with practical preclinical and clinical development strategy, is critical for the approval of new and important therapies in the US and global arenas. Consideration of, and preparation for, key pre-IND consultations, strategic preclinical programs, the important Phase 1/2 and Phase 2/3 decision points, and preparation for pre-BLA and pre-NDA meetings allows Sponsors to meet their milestones. Successful regulatory strategies are often guided by experienced development partners and consulting firms such as Ground Zero Pharmaceuticals."
In related developments, GZP's Sr. Director, Finance and Operations, Ms. Tisha Holle, has been promoted to the position of Vice President, Finance and Operations. Ms. Holle has been with GZP since shortly after its founding in 1999. In addition, Dr. Michael Hamrell, Editor and Chief of the Drug Information Journal and former FDA Pharmacologist, and Dr. Mark Bradshaw, former Vice President, Global Data Management and Biostatistics at Covance, Inc., have been added to our Core Team.
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 compliance, 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; Princeton, New Jersey, Phoenix, Arizona; Orlando, Florida; British Columbia, Canada; Noosa, Australia; London, UK 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, firstname.lastname@example.org, http://www.groundzerous.com.
Ground Zero Pharmaceuticals, Inc.