This is for consulting services for Senior Staff.

这是为高级职员提供咨询服务。

• 批准号: 10949734
• 金额: $ 1万
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-17 至 2024-07-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10949734
• 关键词: consulting; services; Senior; Staff.

Non-Clinical Development consultants will provide leadership in support of the full process of product development for regulatory approval for NIH biologics programs. Consultants will be asked to provide guidance on IND-enabling studies to ensure that teams meet the guidelines and timelines of IND applications. Consultants will serve as the principal regulatory contact with NIH staff, PIs, and regulatory agencies, and may also be the primary regulatory representative to the FDA.

非临床开发顾问将提供领导，支持产品开发的全过程，以获得NIH生物制剂项目的监管批准。顾问将被要求提供IND使能研究的指导，以确保团队符合IND申请的指导方针和时间表。顾问将作为NIH工作人员、PI和监管机构的主要监管联系人，也可能是FDA的主要监管代表。