Gulf Cooperation Council countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates) have implemented eCTD format for submissions as per the following schedule:
GCC countries follow the GCC eCTD specifications, common for the entire region. This includes a specific Module 1.
Asphalion ensures that eCTD submission will always follow the most updated Module 1 specifications and validation rules (current Module 1 version for GCC Countries is v1.5).
When needed or required, Asphalion can give you support on preparing physical media to be exchanged with the Regulatory Authorities (CD/DVD or paper copies).
Contact us for more information.
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
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