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

该合同将为NIAID提供广泛而灵活的非传统，主动和以开发为导向的能力，为有前途的产品提供临床前开发支持，当这些产品从制药商发起的研究中出现时。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工作人员提供小规模生产、临床前试验和文件编制所需的所有支持，以便提交研究性新药（IND）进行I、II和III期临床试验。

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.