Strategic Guidance

GZP focuses individually and intensively on each client program to offer the best strategic advice for facilitated medical product development. By gathering a comprehensive understanding of all available client data, combined with global expertise, GZP makes specific suggestions based on the entire package.

Integrated Quality

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.

Experienced Leaders

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 professional team provides clients with expertise on which they can consistently depend.

We Chart Your Course Through the FDA

Ground Zero Pharmaceuticals, Inc. (GZP) focuses on bringing medical product programs through the FDA regulatory process, from late discovery through final approval and postmarketing. GZP’s philosophy of doing “what is necessary and sufficient and no more” at each stage of development aids clients via clean, cost-effective, targeted and accelerated development plans. With emphasis on completing each portion of a product's lifecycle in a rapid and resource sparing manner, while maintaining acceptable quality for FDA review, GZP adds value to our client programs by enabling accomplishment of important milestones.

How We Help

  • Strategic and Tactical Regulatory Program Execution
  • PreClinical and Clinical Program Development and Implementation
  • Relationship Building with Regulatory Agencies
  • Chemistry, Manufacturing and Controls Consultation
  • Integrated Product Development
  • Product Portfolio Management

FDA Morale in the New Era of Deregulation

5/4/2017 / by Dr. Evan Siegel     Effects on FDA Morale and the Potential for en masse Resignations of that Agency’s Reviewers In a previous blog we identified several critical processes that could be affected if there were major changes in the laws underpinning FDA review and approval of new drugs, biological therapies and vaccines. Should Congress make major modifications in the Food, Drug and Cosmetics and Public Health Service Acts, ...