Country: Switzerland
Health Authority: Swissmedic
eCTD, Accepted Since: October 30, 2009
eCTD Version: Module 1 Specification v1.5 and M2-M5 – v3.2.2 and v4.0

Types of Applications

Initial submissions, Responses, Variations

Process to be followed to make a Swissmedic eCTD submission

  • Learn about the Swiss M1 Specification for eCTD requirements
  • Review the eCTD submission guidance
  • Submit administrative forms and compliant PDFs
  • Request for the application number
  • Submit the eCTD submission via electronic media

Challenges faced in making a Swissmedic eCTD submission

  • Requires cutting-edge technology and seasoned staff
  • Not all the content is in a standard format. Hence standardization is required
  • Difficult to implement last minute changes
  • Local affiliates have limited access to create or customize
  • Baseline submissions are costly and likely to be of limited value
  • Lifecycle management
  • Consolidated approach to drafting of dossier

How can Freyr help?

  • Guarantee your ROI with an eCTD software that optimizes cost-per-submission
  • Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
  • eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
    For more information on the same, consult us

Other Countries

USA, EU, Health Canada, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN


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