Sonali Sri
Senior Regulatory Associate
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About
9+years of experience primarily in the area of the production of submissions and delivery of regulatory services by defined agency guidelines while balancing the quality and timeliness of customer deliverables.
1000+ life-cycle submissions (amendment to original application and Variations, Renewal, Annual
Report and PADER/PSUR) to US, EU, GCC, Canada, Australia, Switzerland and other eCTD & NeeS accepting countries
PUBLISHING TOOLS USED
- Adobe Acrobat Professional XI
- PDF Tool (ISI Toolbox & Smartdesk )
- eCTD Software (eCTDXPress, Insight Publisher, Pharmaready)
- eCTD Viewer (eCTDviewer, Insight viewer, GDMS, DMS and Veeva viewer)
- eCTD eValidator (Lorenz and Insight Validator, Pharmaready)
Experience
9+years of experience primarily in the area of the production of submissions and delivery of regulatory services by defined agency guidelines while balancing the quality and timeliness of customer deliverables.
1000+ life-cycle submissions (amendment to original application and Variations, Renewal, Annual
Report and PADER/PSUR) to US, EU, GCC, Canada, Australia, Switzerland and other eCTD & NeeS accepting countries
PUBLISHING TOOLS USED
- Adobe Acrobat Professional XI
- PDF Tool (ISI Toolbox & Smartdesk )
- eCTD Software (eCTDXPress, Insight Publisher, Pharmaready)
- eCTD Viewer (eCTDviewer, Insight viewer, GDMS, DMS and Veeva viewer)
- eCTD eValidator (Lorenz and Insight Validator, Pharmaready)
Education
M.Pharmacy in Drug Regulatory Affairs
Prepared a thesis on the topic “Evolving eCTD Submission Requirements Across the Globe” which has the overview of the eCTD requirements, the standards for electronic transmission of the submission, and the evolving standards for datasets and variables supporting electronic data interchange globally. It also discusses the issues related to the electronic submission of the applications
