A Dossier Submission Tool

Dossier Submission made easy

Synapse electronic Publisher (SeP) is a new generation submission tools that enables the pharma companies to perform their dossiers submission to Health Authority at ease.
SeP in an overview, is an eCTD Software to compile your eCTD dossiers effortlessly with immaculate precision taking into consideration all the norms as framed by the regulatory authorities.

The SEP Advantage

SeP application will ensure customers in Publishing, Compilation, Validation and generation s dossiers which meets the specification of regulatory agencies across different countries globally.

  • Investigational New Drug Application/Clinical Drug Application (CTA)
  • New Drug Application/Marketing Authorization Application
  • Abbreviated New Drug Application
  • Drug Master File/Active Substance Master File
  • Biological License Application

  • Electronic Common Technical Document (eCTD) and Non- eCTD electronic Submissions (Nees)
  • Region specific eCTD Dossier publishing & submission planning and life cycle management
  • Compliant with US FDA and EU EMA