Regular-term Consultant (e.g. %FTE), CMC and Regulatory, Development and Justifications (for IND, NDA) Consulting Questions

IND Preparation US Team (All FDA Experience, Many Successful Cases) FDA IND Submission

REGeCTD Software (US) - eCTD publishing software (for US FDA) Professional Online or Windows Desktop

Prepare Nonclinical/Clinical - SEND and SDTM Datasets Data Management >> XPT Files >> eCTD Submission

eCTD publishing software (for US FDA) | Professional Online or Desktop | FDA regulatory expert assist (Dr. Robert Lu) Assistance in eCTD Publishing/Submission and in Writing/Reviewing FDA Submissions. eCTD 申报编辑软件 专业网上版 (专业桌面版) FDA regulatory 专家审核帮助 帮助FDA申报文件的准备撰写和寻求法规指南依据要求 医药药品电子模块格式的注册和验证 应用程序系统 STF XML (Keywords)