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,
info@groundzerous.com, http://www.groundzerous.com.
SOURCE Ground Zero Pharmaceuticals, Inc.
 back to top
Related links:
http://www.groundzerous.com
CONTACT:
Evan B. Siegel, Ph.D., of Ground Zero
Pharmaceuticals, Inc., +1-949-852-3666, or fax, +1-949-852-3655,
info@groundzerous.com
|
