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