Asha Sirsath

Background

About Asha Sirsath

Submission Publishing Activity: • Perform electronic submission on eCTD express for Market US • Performing promotional labelling (PRA) submission (including Pre-submission and hyperlinking) FDA submission Via USFDA ESG gateway (NDA, BLA). • Promotional submissions publishing and uploading for biologics and synthetic product via eCTD dossier format. • Review, Compilation, Publishing and Submission of US application like NDA and EU submission like CP, MRP, DCP and national in eCTD format. • Compiling document using eCTD express and cross-reviewing, generating output in CTD format by using ISI publishing tool. • Reserving eCTD sequence prior to additional document and cross checking. • Validation of compile output by LORENZ eValidator. • Performing peer review and QC check before submission. • Tools used SMRT, CARA, CRI, eCTDXpress, Lorenz eValidator, Publishing tool, Veeva (ERV). Print & Dispatch: • Dispatch activity for Gateway submission, eCTD for US, Non eCTD, AU, EU, CESP submission and ROW market dispatch in paper print, email, CD-DVD, electronic and box dispatch. • Support submission manger to print dossiers, burn CDs/DVDs and submit electronic output country specific regulatory requirements. • Performing complex NAP (National Application Procedure) Submission for multiple countries of EU region (Via EMA and CESP portal). • Preparing EMA submission’s delivery file in xml backbone as per assigned request (i.e, CP, PSUSA, PIP And CESP delivery file for National, DCP and MRP).