eSubmit Master

Introduction

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

Features of eSubmit master:

  • Managing complex submission made easy i.e. rolling submission, when publishing IND or NDA with large number of documents. Submission Dashboard and issue analysis Report sent to publishers to view the status of submission during ‘build’’ stage which reduces the burden of workload and Issue management
  • Document level publishing with in eSubmit master, in-built PDF editing feature enables publisher to modify PDF documents also included additional validation for document/submission compliant
  • Validation checks are captured as same as third party tools, report generated will be directed to exact issue and provide suggestion to fix the issue
  • Robust reports that can be accessed via varied electronic devices

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-eCTD

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

EU-eCTD

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

EU & ROW

  • 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)