SWISSMEDIC eCTD

SWISSMEDIC eCTD

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

Types of Applications

Initial submissions, Responses, Variations

Process

  • 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

  • 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

References