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.
- 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