Vasundhara Gaddam Email & Phone Number

Currently working as a Senior Executive in Regulatory affairs department of Natco pharma Ltd from August 2022 to till date.Sr. Executive- Formulation Regulatory Affairs:Compilation and submission of ANDAs for US market and Compilation of ANDS for Canada. Previously compiled product registration dossiers in country specific formats for Brazil or ROW markets. Responsible for review of all approved quality study reports such as PDR, BMR, Specifications, Process Qualification, Process Validation, Analytical Method Validation, Hold Time Protocol & Reports, Stability Protocols & Reports etc. required for submission. Responding to the technical queries sent by the agencies in specified time limit. Involved in post-approval life-cycle management activities for US market like PAS, CBE-30/CBE-0 Writing controlled correspondences to USFDA. End to End interactions with regulatory partners and responsible for organizing meetings in synergy with the business development team for timely submission of dossiers. Review of artworks (PIL, Carton, Foil and label). Knowledge on electronic submissions using PHARMAREADY. Regulatory assessment and approval of Change Controls through AMPLE LOGIC and QAMS as part of Change Management System. Well Versed in ICH Guidelines quality and knowledge of USFDA and CANADA guidelines.

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  Vijaya College Of Pharmacy Affiliated Jntuh

  Pharmaceutical Sciences