About Us
In 1999, Ground Zero Pharmaceuticals, Inc. (GZP) (and, later, its wholly owned Australian subsidiary, Ground Zero Pharmaceuticals, Pty Ltd.) was established as an integrated consulting firm. We now have offices in Irvine, California, USA; Brisbane, Queensland, Australia; and Melbourne, Victoria, Australia, with associates throughout the US, Australia, Canada, Germany and Sweden.
GZP provides its clients with expert strategic and tactical guidance – with an eye toward the global regulatory gold standard, the US FDA – to help develop their products, build their firms, set the appropriate priorities from their pipelines, obtain marketing approvals and pursue postmarketing activities. Our top priority is to maximize the efficiency of the therapeutic development process by reducing duplicative work, proactively identifying issues in a straightforward manner and facilitating interactions with regulatory agencies, financiers and outside vendors. Each stage of the product development cycle is considered with a targeted approach to all clients and individual programs.
How We Help
Strategic Guidance
GZP focuses on tailoring each client program to offer the best strategic advice for facilitated medical product progress toward the ultimate milestone – product approval. Instead of quoting FDA guidelines, GZP gathers a comprehensive understanding of all client data available, combines this with global expertise, and makes specific suggestions based on the entire package. The regulatory environment is always changing, new technologies are being developed and the FDA is constantly refining what it requires of Sponsors. Each key question may have a number of “correct answers,” and GZP understands that individual data points, studies and supporting documentation, channeled in a logical and targeted manner, can lead to a “yes” answer from the Agency.
Integrated Quality
GZP takes an integrated approach to product development in its people as well as in its philosophy. With team members who have backgrounds in more than one discipline and a focus on efficient team interaction, we provide our clients with a unique approach to executing their projects. GZP understands that each subset of technical versatility (regulatory strategy, preclinical/nonclinical, clinical, and chemistry, manufacturing and controls) affects others in all phases of development. GZP constantly considers each of these nodal disciplines when moving a client’s program through the regulatory process. Strategic regulatory considerations are woven throughout the fabric of a program to best facilitate movement toward the goal of marketing approval. By integrating all relevant technical disciplines toward problem solving, we have found that FDA Reviewers and Sponsors alike can negotiate solutions in less time and with more flexibility than the traditional “divide and conquer” philosophy.
Experienced Leaders
With an average of over 25 years’ experience each in their respective disciplines (Regulatory Affairs, CMC/Product Quality, Preclinical/Nonclinical, Clinical, Medical Writing, Project Management, and Electronic Submissions), under the purview of the FDA, EMA and other regulatory oversight agencies, GZP’s core professional team provides clients with expertise on which they can consistently depend. GZP team members have been involved in the development of many of the cutting-edge technologies that have emerged as both blockbuster drugs and those invoking use of evolving newer technologies with groundbreaking promise, including novel monoclonal constructs, somatic cell therapies, oncolytic virus therapies and treatment vaccines. With GZP having experience across more than 18 therapeutic areas, and in highly specialized fields, our clients receive high-quality, tailored, practical advice in biologic/biotechnology, pharmaceutical, medical device and combination product development.