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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, Inc. provides integrated consultation in regulatory affairs, toxicology, pharmacology, clinical development, biostatistics, CMC, medical writing, electronic submissions and project management for pharmaceutical, biologic, medical device and combination product programs.
With extensive experience in small molecule, proteins, monoclonal antibodies, vaccines, and cellular therapies, GZP provides services tailored to our clients’ unique program needs.
GZP offers a full range of regulatory services for medical device companies. Our strategic regulatory services provide expertise in the overall planning and execution of regulatory compliance through all phases of the device lifecycle.
Ground Zero Pharmaceuticals, Inc. provides technology assessment of intellectual property owned by individuals or virtual and small firms, as well as on behalf of venture capitalists, pharmaceutical partners and others. This includes the scientific and technical review of the data and other information in a firm’s product portfolio, with recommendations on the most likely scenarios for regulatory and clinical success.
Tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, […]
Tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, […]
Tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, […]