• Regular-term Consultant (e.g. %FTE), CMC and Regulatory, Development and Justifications (for IND, NDA) Ask Dr. Lu

• 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)