Regulatory OperationsCTD/eCTD

We provide contract services for CTD/eCTD compilation and New Drug Application (NDA) / Marketing Authorization Application (MAA) support services that meet optimal balance among nature of application, volume of data and total cost.
Moreover, we present a line of tools with functions specialized in NDA/MAA

  • SWIFTeS - Tool for support of NDA document creation
  • SWIFTeS Proof - Microsoft Word Text Proofreading Tool
  • ISIToolBox - PDF processing tool
  • eCTDXPress - eCTD compilation system
  • ISIPublisher - Publishing system
  • OpenFlow - PDF rendition/publishing system
  • Document management system implementation support
  • eCTD compilation system implementation support
  • NDA/MAA outsourcing
  • eCTD submission assessment and consulting service
  • Medical writing services
  • Consulting and outsourcing service of global regulatory submission
  • Public document masking service
  • Clinical - cloud solution to comprehensively support pharmaceutical development
  • CSV consulting services
  • Basic support services for the new CSV guidelines

Pharmaceutical Business Solutions