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.

OUR SERVICES

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.

BIOLOGICS / PHARMACEUTICALS

With extensive experience in small molecule, proteins, monoclonal antibodies, vaccines, and cellular therapies, GZP provides services tailored to our clients’ unique program needs.

 

 

MEDICAL DEVICES

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.

TECHNOLOGY ASSESSMENT

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.

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

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