IRVINE, Calif., Nov. 4, 2015 /PRNewswire/ -- GZP announces Expansion of its Biostatistical and Electronic Submission Services. As clinical trials become more varied in design and adaptive approaches more common in small molecule and biologic drug programs, consulting firms must respond and anticipate the needs of its clients. GZP has recently bolstered its sophisticated biostatistical and clinical operations staff to design, review, and analyze its client’s clinical trial protocols and results. The firm also has increased its local Australian regulatory presence for interaction with Ethics Committees and the TGA, in response to requests from clients who desired this expertise.
GZP has furthered its “V-Team” initiative to augment the most critical resources in early stage firms. This V-Team includes GZP team members with an average of more than 24 years’ experience in their areas of concentration, and are typically multidisciplinary. Including experienced C-level executives, they have worked in small and large pharma, biotechnology firms, CROs, and regulatory agencies, thus providing a unique perspective to apply to client projects.
This true partnership provides access to 8 high-level experts on a regular basis for all of a firm’s strategic preclinical/nonclinical, CMC, clinical, medical writing and regulatory development needs, including submissions and FDA meetings. This allows the client to better project costs; the ability to use even more specialized resources when necessary; and most importantly, fostering rapid and facilitated progress towards investor accepted milestones.
In 2015, GZP increased its electronic submission capabilities and output; as of October we have submitted eight electronic INDs in 2015 alone, anticipating a deadline of mid-2018 for all commercial INDs to the FDA in electronic form. The firm facilitated more than 75 meetings and other communications with the FDA, from pre-pre-IND through End of Phase 2, and responded to the increasing approach of the Agency to “written response only” consultations as well as the typical in-person and telecon meetings. GZP believes that early, frequent, targeted, and creative FDA communication leads to successful product development, attracts additional funding and furthers the desire of many small firms to partner with their consultants rather than using them for specific tasks in a “hands off” manner.
According to Evan Siegel, “The FDA and other regulatory agencies are responding to the needs of healthcare professionals and patients by improving communication with industry, developing and furthering accelerated programs, such as Breakthrough Therapy Designation, for medical product development and approvals, and at the same time insisting on higher quality data and regulatory compliance. Along with these changes, rare and life-threatening disease initiatives require cooperative and intensely responsive communications with consultants and corporate management. GZP is perfectly positioned to deal with these challenges and guide clients in a positive and productive direction.”
Dr. Siegel will be in Australia speaking at seminars in Brisbane and Adelaide from November 6-20.
Based in Irvine, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs, product development, and clinical consulting firm providing strategic and tactical services to the pharmaceutical, biotechnology and medical device industries. These include regulatory representation and submissions, preclinical and clinical planning, auditing of clinical, nonclinical and manufacturing sites, medical writing, chemistry, manufacturing and controls consulting, biostatistical assessment, and project management. GZP has resources throughout the US, Canada, Australia and Europe, and a wholly owned subsidiary in Australia.
For further information contact Ms. Tisha Templeton, Senior Vice President, Finance and Operations, Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, ttempleton@groundzerous.com.
Web Site: http://www.groundzerous.com
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SOURCE Ground Zero Pharmaceuticals, Inc.
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