Personal Information
Organización/Lugar de trabajo
Bangladesh Bangladesh
Ocupación
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
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...
Etiquetas
generic drug
bio waiver
bio equivalence
Ver más
Presentaciones
(2)Recomendaciones
(3)HPLC
Saritha Alladi
•
Hace 10 años
Pharmaceutical Design of Experiments for Beginners
GMP EDUCATION : Not for Profit Organization
•
Hace 8 años
ANDA Submissions :When will FDA Refuse to Accept an ANDA
GMP EDUCATION : Not for Profit Organization
•
Hace 9 años
Personal Information
Organización/Lugar de trabajo
Bangladesh Bangladesh
Ocupación
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
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...
Etiquetas
generic drug
bio waiver
bio equivalence
Ver más