Nikita Bodke
Technical Associate @Genpact
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WORK HISTORY
Technical Associate @Genpact
Mumbai, IN
EDUCATION
Vishal institute of pharmaceutical education and research
Bachelor's degree
Dr. Bhanuben Nanavati College of Pharmacy
Master's degree
ABOUT NIKITA BODKE
1.8 years experience in ANDA dossier preparation and minor query Response like (IR, DRL & CRL Quality)Post-approval - preparation & submission of annual report for US market.dossiers preparation for submission of PAS(additional strength, additional API source).labellingeCTD Submission publishing for US and AU Market. compilation and submission of PADERs. Documents review - FP & API specifications, testing and sampling plan, declaration, stability data for US market & BPR for ROW market.currently I am submission planner for US Annual Report.currently I am passionately looking for the eCTD Submission publishing role in a reputed organization (MNC).
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