EXTEDO will partner with the National Health Regulatory Authority to support the standardization of the electronic submission management process within the Kingdom of Bahrain as part of the Gulf Cooperation Council (GCC) region. The agreement between the authority and EXTEDO includes deploying EXTEDO´s EURS solution to support the reviewing and validating of electronic submissions.
After the Kingdom of Saudi Arabia, the Sultanate of Oman, and the United Arab Emirates, the Kingdom of Bahrain is the fourth country within the GCC member states to adopt the eCTD standard.
EXTEDO will be offering its product portfolio to the Ministry of Health of Bahrain, including submission management and publishing tool eCTDmanager and submission validation software EURSvalidator, which will enable pharmaceutical companies to submit their regional electronic submissions.
About eCTDmanager
eCTDmanager is an easy-to-use solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
About EURS
EURS is a software solution that serves as an overall eCTD validation and reviewing software tool used by more than 35 authorities worldwide
About EURSvalidator
EURSvalidator is the leading electronic submission validation engine used by more than 35 regulatory authorities worldwide.
“The Kingdom of Bahrain is an important partner for us. As a vital member of the Gulf Cooperation Council region, we are honored to be the partner of choice in delivering software solutions and services that will support the needs of organizations operating within Bahrain.”
Martin Schmid, Managing Director EXTEDO
About the National Health Regulatory Authority
The National Health Regulatory Authority, which began operating in 2010, is responsible for licensing and regulating healthcare professionals, healthcare facilities, and medicines in the Kingdom of Bahrain. They aim to provide people with the support they need as an applicant, license holder, or member of the public.
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