Ground Zero Pharmaceuticals (GZP) specializes in providing comprehensive strategic guidance for medical product development, focusing on navigating the FDA regulatory process from late discovery to final approval and post-marketing. The company emphasizes an integrated approach to product development, leveraging the diverse expertise of its team members, who average over 25 years of experience in various disciplines such as regulatory affairs, clinical development, and medical writing. GZP's methodology is designed to create clean, cost-effective, and accelerated development plans that maintain high-quality standards for FDA review, ultimately helping clients achieve critical milestones in their product lifecycle.

In addition to regulatory affairs, GZP offers a wide range of services tailored to the unique needs of its clients, including consultation in toxicology, pharmacology, biostatistics, and project management for pharmaceuticals, biologics, medical devices, and combination products. The company also conducts technology assessments for intellectual property, providing scientific and technical reviews to identify the most promising pathways for regulatory and clinical success. With extensive experience in various therapeutic areas, including small molecules, proteins, and cellular therapies, GZP is well-equipped to support clients throughout the entire development process.

United States

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.

Ground Zero Pharmaceuticals

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