BJ Promotor
CTD dossier translation for drug IND/NDA

Beijing, Beijing, China
Local time: 13:51 CST (GMT+8)
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Keywords: IND/NDA dossiers, CMC, toxicity study, pharmacodynamic study, pharmacokinetic study, clinical trial, PSUR, DUSR, SSUR, protocol. See more.IND/NDA dossiers, CMC, toxicity study, pharmacodynamic study, pharmacokinetic study, clinical trial, PSUR, DUSR, SSUR, protocol, clinical study report, AE line listing, drug safety, chemical synthesis, manufacturing, quality control, analytical procedure, validation of analytical procedure, specification, formulation study, clinical overview, clinical summary, preclinical overview, quality overall summary, guideline, CIOMS, Data Management Plan, statistical analytical plan, Container Closure Integrity, biosimilar, Investigator Brochure, synopsis, annual report, risk management plan, SmPC, Protocol Elements Document, informed content form (ICF), SUSAR, SAE report, ADME report, USPI, Elucidation of Structure, labeling, . See less.


Profile last updated
Sep 12, 2017