Execute regulatory strategies by authoring and review of submission components for supplements (CBE-0, CBE-30 and PAS)/variations (type 1A, type 1b, type II) and Annual reports. Handling labeling activities (RLD Label updates) and preparation of labels in Structure Product Labeling (SPL) format and reviewing the SmPC, Pil Handling Publishing Activities with ISI Toolbox, eCTD tool PharmaReady and Lorenz eValidator.Preparation and Compilation of Module-1,2,3,5 of Dossiers (ANDA, ANDS, EU dossier, UK dossier etc,) and submit to US, Canada and Europe Markets. Activities.Handling Regulatory Information Management System (RIMS) Activities.

Change Control Assessments - US, Europe, Canada, Australia and NZ through QMS TrackwiseRIMS Activities - Through Sparta SystemsEurope Launch ActivitiesQOS and Analytical Sections PreparationApproved Product Package PreparationData Reliability Assessments Reports Preparation

Analyzed and Compiled Data of Various Regulatory Queries.Analytical Method Validation.Development of Dissolution, Assay methods for Pharmaceutical Products.Analysis of Routine, Development Stability and Exhibit Stability Samples.Calibration of Instruments like pH meter, Analytical Balances, Dissolution, UV-Visible Spectrophotometer, HPLC, UPLC and GC.Contemporaneous error free documentation of delivered data.