Established in California in 1987 as an individual consultancy, Ground Zero Strategics, Ltd. has grown into an integrated consulting firm, Ground Zero Pharmaceuticals, Inc. (GZP) with a wholly owned Australian subsidiary, Ground Zero Pharmaceuticals, Pty Ltd., and membership in BioSuccess Ventures LLC. We have offices in Irvine, California; USA, Brisbane, QLD Australia; and Melbourne, VIC Australia, with Associates throughout the US, Australia, Canada, Germany and Sweden.
GZP provides expert strategic and tactical guidance for our clients 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.
GZP focuses individually and intensively on each client program to offer the best strategic advice for facilitated medical product progress. Instead of simply 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, to provide the best advice for a particular program, 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. This understanding is critical to successful negotiations via the regulatory process. With this approach, GZP provides specific strategic advice on a project, always focused on helping clients achieve the next milestone, with consideration of the ultimate milestone – product approval.
GZP takes an integrated approach to product development in its people as well as its philosophy. Team members with backgrounds in more than one discipline and efficient team interaction 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 the other in all phases of development. GZP constantly considers each of these nodal disciplines when moving a client program through the regulatory process. Strategic regulatory considerations are woven throughout the fabric of a program to best facilitate movement towards the ultimate goal of marketing approval, by a client, marketing partner, or outlicensee. By integrating all relevant technical disciplines towards 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.
With an average of over 25 years each in their respective disciplines (Regulatory Affairs/Submissions, CMC/Product Quality; Preclinical/Nonclinical; Clinical; and Medical Writing), 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 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.