Personal Information
Organização/Local de trabalho
Bangladesh Bangladesh
Cargo
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Setor
Medical / Health Care / Pharmaceuticals
Sobre
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...
Marcadores
generic drug
bio waiver
bio equivalence
Ver mais
Apresentações
(2)Gostaram
(3)HPLC
Saritha Alladi
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Há 10 anos
Pharmaceutical Design of Experiments for Beginners
GMP EDUCATION : Not for Profit Organization
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Há 8 anos
ANDA Submissions :When will FDA Refuse to Accept an ANDA
GMP EDUCATION : Not for Profit Organization
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Há 9 anos
Personal Information
Organização/Local de trabalho
Bangladesh Bangladesh
Cargo
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Setor
Medical / Health Care / Pharmaceuticals
Sobre
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...
Marcadores
generic drug
bio waiver
bio equivalence
Ver mais