/ http://www.slideshare.net/images/logo.gif / ºÝºÝߣShare feed for ºÝºÝߣshows by User: bhargavdesai3 https://cdn.slidesharecdn.com/profile-photo-bhargavdesai3-48x48.jpg?cb=1682828039 • Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities. • Provided regulatory guidance and expedite responses to regulatory authorities. Ensure documentation complies with regulations for international submissions. • Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, Batch records, Stability, Finished product / Packaging material data for the purpose of compilation of the dossier. • Review of documents required for regulatory agencies (Viz. Analytical reports, Process Validation Report, Process Validation Protocol, Master Formula Record, Batch Manufacturing Record, Pharmaceutical...