Sachin Gundecha
22
Seguidores
Personal Information
Organização/Local de trabalho
Pune Area, India India
Cargo
Senior Manager Regulatory Affairs
Setor
Medical / Health Care / Pharmaceuticals
Sobre
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.
- Apresentações
- Documentos
- Infográficos
vendor validation by akshay kakde
Akshay Kakde
•
Há 7 anos
Back To Basic Gmp
Remedios Rivera
•
Há 15 anos
US FDA Process Validation Stage 2 : No. Of Batches Required for Process Performance Qualification.
GMP EDUCATION : Not for Profit Organization
•
Há 8 anos
USFDA NDA Vs BLA
Girish Swami
•
Há 10 anos
CTD and eCTD
Girish Swami
•
Há 11 anos