Madhavi Bandaru
Regulatory Affairs @Hetero
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WORK HISTORY
Regulatory Affairs @Hetero
Hyderabad, IN
Dossier filings for Europe market.
EDUCATION
Oxford Jr college
Inter
Z.p.g.h School in Macherla
Bpharmacy , Mpharmacy
ABOUT MADHAVI BANDARU
I am presently associated with Vimta Labs Ltd, Hyderabad as an Sr.Data coordinator in theMedical Writing domain. I am an dedicated professional having strong medical writing and analyticalskills to create, edit and producing of clinical and scientific documents (Phase I, II, and IV)including clinical summaries, clinical study protocols, ICFs, clinical study reports (CSRs), CTDmodules 2.5 (clinical overview), 2.7 (clinical summary), investigator’s brochure (IBs), SAP, CRFs,DBE Tables, CS-BE Tables, PD tables for vasoconstriction studies, clinical endpoint summary tablesfor skin irritation and sensitization, adhesion studies and additional documents required for dossiersubmission in compliance with GCP and applicable regulatory guidelines and Preparation of clinicallisting in the formatting eCTD Preparation of Various regulatory submitting eCTD Reports likeUSFDA, Other regulatory submissions.
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