NIAID PRECLINICAL DEVELOPMENT SUPPORT - REQUALIFICATION AUDITS OF CGMP/GLP FACILITIES

这份合同将为NIAID提供广泛和灵活的非传统、前瞻性和面向开发的能力，当有前景的产品从研究人员发起的研究中出现时，为这些产品提供临床前开发支持。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。承包商应协助NIAID工作人员为小规模生产、临床前测试和文件提供所需的所有支持，以提交第一、第二和第三阶段临床测试的研究用新药(IND)。

This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing.