regulatory submission的意思
regulatory submission中文翻譯:
監督意見書
submission───n.投降;提交(物);服從;(向法官提出的)意見;謙恭
submission confirmation───提交確認
regulatory approval───注冊審批;監管批準
submission status───提交狀態
manuscript submission───投稿
regulatory affairs───法規事務
submission deadline───提交最終期限;提交截止日期
regulatory risk───監管風險
regulatory sandbox───監管沙箱
For more information on electronic submissions, see electronic Regulatory submission and Review.───關于電子遞交方面的更多信息,請參見電子格式遞交及評審。
Support Regulatory Affairs as needed for domestic and international submissions from manufacturing perspective required by the US FDA, China CFDA and international submission in designated countries.───支持本地和國際法務工作,需要時支持中國和國際生產注冊提交,以符合美國FDA及中國FDA和各國的要求。
Statutory or other regulatory requirements may demand minimum retention periods or submission to an authorizing body such as an archival authority or auditors for any necessary approval.───法規或其他規章需求可能會訂定最小保存期限或要求將此事交給一個經授權的機構,例如:具認可之檔案主管機構或稽核單位。
Working with relevant function within Company responsible for the submission content to prepare the regulatory submission.───協調公司內部相關注冊支持部門的工作,進行注冊資料的準備。
P. 2 Pharmaceutical Development section of a regulatory submission in the ICH M4 Common Technical document (CTD) format.───藥品開發章節中關于以ICHM4通用技術文件(CTD)格式提交藥政申請的建議內容進行描述。
For more information on electronic submissions, see Electronic Regulatory Submission and Review.───關于電子遞交方面的更多信息,請參見電子格式遞交及評審。
Roche said it expects a global regulatory submission by the middle of 2012.───羅氏制藥公司表示,預計將于2012年年中向全球藥物監管部門提交申請。
Idea is to harmonize the organization of a regulatory submission───主旨是協調遞交形式的管理?
Responsible for clinical part of regulatory submission dossier and answering questions raised by CDE───負責新產品注冊資料臨床部分的準備并解答CDE提出的問題
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