eSubmit Master

eSubmit master is a publishing software, 21CFRPART11 compliant which cater the electronic business solution to pharmaceutical companies, filing dossiers to various Health Authorities like USA and European Union etc. in eCTD, NeeS or Paper. Our Regulatory thought leaders analysed challenges faced by Regulatory personnel with different roles like Publishers, Publishing Managers, workload managers etc. while publishing electronic submission using software tools. eSubmit master with unique and adequate features that reduces timeline to build an electronic submission. eSubmit master ‘’state of the art’’ technology solution with highly integrated features that benefits major challenges which includes

US-FDA

  • Investigational New Drug application(IND)
  • New Drug Application(NDA)
  • Biologics License Application(BLA)
  • Abbreviated New Drug Appliaction(ANDA)
  • Drug Master File(DMF)

EU & ROW

  • NeeS (Non- electronic eCTD submission)
  • Merged PDF
  • Paper submission (CTD)
  • Paediatric Investigational Plan (PIP)
  • Amendments

EU-eCTD

  • Centralized Procedure (CP)
  • Mutual recognition Procedure (MRP)
  • Decentralized Procedure (DCP)
  • Variations (Type 1A, 1B, II)
  • Responses
  • Amendments

Safety Report

  • IND Annual reports
  • Annual Safety report (ASR)
  • Development Safety Report (DSUR)
  • Investigator’s Brochure (IB)
  • Periodic Safety Update report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)

Partners