Personal Information
Unternehmen/Arbeitsplatz
Bangladesh Bangladesh
Beruf
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Branche
Medical / Health Care / Pharmaceuticals
Info
Have been working with ACME since February 2011. My main obligation is to prepare Registration DOSSIER as per the regulatory requirement of the respective country. Successfully prepared more than 100 DOSSIER in isolated format like ACTD, CTD etc. and submitted to more than 20 Countries.
Capable and also have experienced of Preparing quality documents like Site Master File (SMF), Validation Master Plan (VMP), SOP, Company registration documents with foreign drug regulatory authority etc.
Able to handle and operate general QC lab equipment, like HPLC, UV Visible Spectrophotometer, Atomic Absorption Spectrophotometer, Infrared spectrophotometer, TOC analyzer, Karl Fischer Tritrator, Pote...
Tags
generic drug
bio waiver
bio equivalence
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Personal Information
Unternehmen/Arbeitsplatz
Bangladesh Bangladesh
Beruf
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Branche
Medical / Health Care / Pharmaceuticals
Info
Have been working with ACME since February 2011. My main obligation is to prepare Registration DOSSIER as per the regulatory requirement of the respective country. Successfully prepared more than 100 DOSSIER in isolated format like ACTD, CTD etc. and submitted to more than 20 Countries.
Capable and also have experienced of Preparing quality documents like Site Master File (SMF), Validation Master Plan (VMP), SOP, Company registration documents with foreign drug regulatory authority etc.
Able to handle and operate general QC lab equipment, like HPLC, UV Visible Spectrophotometer, Atomic Absorption Spectrophotometer, Infrared spectrophotometer, TOC analyzer, Karl Fischer Tritrator, Pote...
Tags
generic drug
bio waiver
bio equivalence
Mehr anzeigen