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Vaishnavi Sundararaman

Regulatory Affairs Associate/Submission publisher @ Novartis

Vaishnavi Sundararaman Contact Details

Passaic, New Jersey
Regulatory Affairs Associate/Submission publisher @ Novartis
Formulation R&D Intern @ RA Chem Pvt Ltd
Research and Development Intern @ Hetero Drugs limited
Bachelor of Pharmacy (B.Pharm.) @ Sri Ramachandra Medical College and Research Institute

Regulatory Affairs Associate/Submission publisher @ As a Submission Publisher I worked on software tools like ISI Publisher, ISI Toolbox, eCTD Xpress and handled various submissions like:- CMC Variations (Type I&II) , Clinical Trial Application (CTA) Answer to HA Questions (AtoQ) , Renewals CMC / CTA Amendments, Annual Reports Line Extensions, Investigational Medicinal Product Dossier (IMPD) Development Safety 

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