EXTEDO will partner with the Ministry of Health to support the standardization of the electronic submission management process within the UAE as part of the Gulf Cooperation Council (GCC) region. The agreement between the authority and EXTEDO includes deploying EXTEDO’s EURS tool to support the reviewing and validate electronic submissions. This is an important milestone for medical security within the GCC member states, with Saudi Arabia, Oman, and the UAE being the first to adopt the eCTD standard.
This new regional partnership, supported by EXTEDO’s local partner MPC, will enable pharmaceutical companies to submit their regional electronic submissions using EXTEDO’s eCTDmanager and EURSvalidator.
- eCTDmanager is an easy-to-use solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
- EURS is a software solution that serves as an overall eCTD validation and reviewing software tool used by more than 30 authorities worldwide
- EURSvalidator is the leading electronic submission validation engine used by more than 30 regulatory authorities worldwide
“We work closely with regulatory authorities and standards bodies around the world to make sure that all of our products fully support the latest standards,” said Martin Schmid, CEO at EXTEDO, “with the new partnership with the Ministry of Health UAE, we’ll be able to expand our global footprint of supporting Health Authorities with their key objectives to make patients life saver.”
EXTEDO is a leading software and solutions provider within the field of Regulatory Information Management (RIM). EXTEDO focuses on optimizing clients’ eRegulatory business processes, and their EXTEDOsuite provides tools to support the complete regulatory landscape.
EXTEDO develops configurable off-the-shelf products, as well as customized and integrated solutions compliant with Medical Product Dictionary. EXTEDO also provides EURS, the validation, review, and approval software solution used by the EMA and over 30 Regulatory Authorities worldwide.
Today EXTEDO serves more than 700 customers in 60 countries, ranging from small companies to large multinational organizations. EXTEDO supports many disciplines within the life sciences area, including pharmaceutical, biotech and biopharma, generics, homeopathy, medical devices, crop sciences, and the public sector. EXTEDO is recognized as one of the worldwide leaders in each of these areas.