NINDS BPN/ Lowery Creek /CMC Consulting Services IGF::CL::IGF

顾问将为LDT成员提供从临床前阶段到初始临床阶段进行小分子化合物药物开发活动的监管要求、流程和物流方面的资源。顾问可能被要求为化学生产和控制（CMC）监管活动提供战略指导，这些活动是实现临床前药物生产、IND研究和临床试验所必需的。

The consultant will serve as a resource to LDT members for the regulatory requirements, processes, and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage. The consultant may be asked to provide strategic guidance for chemical manufacturing and controls (CMC) regulatory activities necessary to enable preclinical drug product manufacturing, IND enabling studies, and clinical trials. The role of the CMC/Pharmaceutics consultant may include but is not limited to the following responsibilities and tasks: • Lead CMC activities for compounds in development, in accordance with the US regulatory and the ICH guidelines. • Provide expertise in drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences leadership in chemical manufacturing, formulation, and product development for small molecules. • Provide CMC guidance and strategy to LDTs, including identifying and assessing regulatory risks. • Ensure the timely preparation, review and submission of CMC documents to regulatory authorities including FDA, EMA and other national authorities, to support the conduct of clinical trials and marketing applications. • Ensure the compliance of CMC activities with applicable regulatory requirements. • Evaluate manufacturing processes and changes, assess regulatory implications and support process implementation. • Assist NIH with inspections and onsite visits with contract organizations. • Maintain current knowledge of the relevant guidelines and regulations and determine applicability to activities. • Provide expertise in dose form selection. • Provide expertise in API development and related activities.