REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

监管事务咨询支持服务

• 批准号: 10949122
• 负责人: LYNN THOMAS
• 金额: $ 1.12万
• 依托单位: CCS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2024-09-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10949122
• 关键词: REGULATORY; AFFAIRS; CONSULTING; SUPPORT; SERVICES

Medical Writing consultants will be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants will coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical protocols, Investigational New Drug applications (INDs), Investigator Brochures (IBs), IND Amendments, Drug Master Files, and Statement of Investigators (Form FDA 1572) and drug dossiers.

医学写作顾问将负责为NIH项目准备和提交高质量的监管和其他支持文件。顾问将与LDT协调，准备、编辑、审查并向监管机构提交文件（例如，FDA）。文件可能包括但不限于临床方案、新药研究申请（IND）、研究者手册（IB）、IND修正案、药物主文件和研究者声明（FDA 1572表）以及药物档案。