Personal Information
Organización/Lugar de trabajo
Hyderabad Area, India India
Ocupación
Looking for Regulatory affairs job opportunities ........
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
I have done M.pharm in Pharmaceutics.
My day to day activity was reated to analyzing post approval changes and filing the apppropriate document for approval of change in US market.
I have worked on CTD filing for Annual Reportable Changes, CBE - 0, CBE- 30 and Prior Approval Supplement submission
I have gained knowledge related to:
Regulatory Affairs
- Knowledge of post approval changes guidelines in US for CMC Changes.
- Change control Management in Trackwise Software.
- eCTD filing on DCM & Citrix Software.
- Knowledge of Drug Approval Process in US.
etc.
Recomendaciones
(159)Professionalism Training
ROUSES63
•
Hace 14 años
Professionalism
FAA Safety Team Central Florida
•
Hace 10 años
Diff bw adult child
Vipin Vageriya
•
Hace 6 años
How to deal with low self esteem – 4 ways
Ethan Musolini
•
Hace 9 años
Q6 guidelines
Anjali Aji
•
Hace 6 años
Merck Group @ Transform conference Europe
Transform magazine
•
Hace 7 años
All about Tablets (Pharma)
Sathish Vemula
•
Hace 9 años
Merck and company interview questions and answers
KateWinslet88
•
Hace 9 años
Guidelines for students applying new passport
valliappan1991
•
Hace 10 años
CHANGE CONTROL
sonia nazir
•
Hace 6 años
Introduction to pharma industry
Girish Swami
•
Hace 8 años
Pharma data integrity
Girish Swami
•
Hace 8 años
CTD and eCTD
Girish Swami
•
Hace 11 años
EMEA
Gaurav Kr
•
Hace 11 años
Comparasion of IND,NDA,BLA,ANDA,OTC
Guru Balaji .S
•
Hace 5 años
NDA/BLA/PMA and 510(k)
Navalika Polishetty
•
Hace 6 años
Vaccine Development & GMP Manufacturing - Creative Biolabs
Creative-Biolabs
•
Hace 5 años
Electronic Common Technical Document (eCTD)
Md. Zakaria Faruki
•
Hace 5 años
eCTD Submissions
Quintiles, Mumbai, India
•
Hace 14 años
CTD and eCTD - Common Technical Document
Darewin Mendonsa
•
Hace 5 años
Regulatory requirement of EU, MHRA and TGA
Himal Barakoti
•
Hace 6 años
Abbreviated New Drug Application [ANDA]
Sagar Savale
•
Hace 7 años
Anda filing
debangshuroy89
•
Hace 12 años
Business Operational Excellence Strategy PowerPoint Presentation Slides
SlideTeam
•
Hace 5 años
Cmc, post approval and regulation
Himal Barakoti
•
Hace 6 años
Formulation Research and Development Services
Cognibrain Healthcare
•
Hace 6 años
Content and format of dossier filling in india
sandeep bansal
•
Hace 5 años
Sain medicaments
IndiaMART InterMESH Limited
•
Hace 12 años
Regulatory Approval Process for Medical Devices in EU - Presentation by Akshay Anand
Akshay Anand
•
Hace 9 años
Personal Information
Organización/Lugar de trabajo
Hyderabad Area, India India
Ocupación
Looking for Regulatory affairs job opportunities ........
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
I have done M.pharm in Pharmaceutics.
My day to day activity was reated to analyzing post approval changes and filing the apppropriate document for approval of change in US market.
I have worked on CTD filing for Annual Reportable Changes, CBE - 0, CBE- 30 and Prior Approval Supplement submission
I have gained knowledge related to:
Regulatory Affairs
- Knowledge of post approval changes guidelines in US for CMC Changes.
- Change control Management in Trackwise Software.
- eCTD filing on DCM & Citrix Software.
- Knowledge of Drug Approval Process in US.
etc.