Sachin Gundecha
22
Seguidores
Personal Information
Organización/Lugar de trabajo
Pune Area, India India
Ocupación
Senior Manager Regulatory Affairs
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
Worked for USA (ANDA).
Review and compilation of ANDA, WHO dossier.
CMC Writing/Annual Report preparation/CBE 30 Filing/Amendments.
WHO pre-qualification dossier.
Worked for ROW market, for Asia and Africa.
Compiled ACTD, CTD, and Other country specific formats.
Filed marketing authorization to TFDA, KFDA,PRA in CTD formats.
Handling query and technical issues of the products.
Providing regulatory support to the company in order to obtain marketing authorization for commercial products.
Strong regulatory background includes knowledge of international registration guidelines & regulations.
The work profile also includes the review of various master documents.
- Presentaciones
- Documentos
- Infografías
vendor validation by akshay kakde
Akshay Kakde
•
Hace 7 años
Back To Basic Gmp
Remedios Rivera
•
Hace 15 años
US FDA Process Validation Stage 2 : No. Of Batches Required for Process Performance Qualification.
GMP EDUCATION : Not for Profit Organization
•
Hace 8 años
USFDA NDA Vs BLA
Girish Swami
•
Hace 10 años
CTD and eCTD
Girish Swami
•
Hace 11 años