Have a look at this infographic prepared by Extedo® and Asphalion with the summary updates in terms of publishing and eSubmission at a regional level. On this occasion, we are focusing on the Gulf Cooperation Council countries!
Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates implemented eCTD format for submissions. GCC countries follow the GCC eCTD specifications, common for the entire region.
ASPHALION and our partner Extedo® can guide you with the transitions in GCC submissions. We can support you in a variety of activities.
Have a look at the document here: ASPHALION & EXTEDO GCC eSUBMISSIONS
For further information you can contact us at: ectd@asphalion.com
