Personal Information
Entreprise/Lieu de travail
Bangladesh Bangladesh
Profession
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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...
Mots-clés
generic drug
bio waiver
bio equivalence
Tout plus
Présentations
(2)J’aime
(3)HPLC
Saritha Alladi
•
il y a 10 ans
Pharmaceutical Design of Experiments for Beginners
GMP EDUCATION : Not for Profit Organization
•
il y a 8 ans
ANDA Submissions :When will FDA Refuse to Accept an ANDA
GMP EDUCATION : Not for Profit Organization
•
il y a 9 ans
Personal Information
Entreprise/Lieu de travail
Bangladesh Bangladesh
Profession
Assistant Manager, Global Regulatory Affairs at The ACME Laboratories Limited.
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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...
Mots-clés
generic drug
bio waiver
bio equivalence
Tout plus