The National Health Regulatory Authority in Kingdom of Bahrain chooses EXTEDO´s EURS solution for validation & reviewing
Manama, Kingdom of Bahrain - August 11, 2016 – EXTEDO, a leading provider of Regulatory Information Management solutions, has signed an agreement with the National Health Regulatory Authority to introduce the electronic submission management standard eCTD within the Kingdom of Bahrain.
(firmenpresse) - EXTEDO will be partnering 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 the deployment of EXTEDO’s EURS solution to support the reviewing and validation of electronic submissions.
After Kingdom of Saudi Arabia, Sultanate of Oman and the United Arab Emirates, 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 the licensing and regulation of 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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Unternehmensinformation / Kurzprofil:
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape. Our EXTEDOsuite combines innovation with compliance, and quality with usability.
Whether planning & tracking, product registration, submission publishing and lifecycle management, pharmacovigilance management and drug safety; we optimize every eRegulatory business process. Today, EXTEDO enables more than 35 regulatory authorities and over 700 maintained customers across 60 countries to deliver Effortless Compliance™.
For more information, visit www.extedo.com.
EXTEDO GmbH
Einsteinstraße 30
85521 Ottobrunn
Germany
Media Contact:
Ina Scharfen
Junior Marketing Specialist
Tel.: +49 89 189 454 184
email: scharfen(at)extedo.com
Datum: 11.08.2016 - 07:20 Uhr
Sprache: Deutsch
News-ID 1452050
Anzahl Zeichen: 2462
contact information:
Contact person: Ina Scharfen
Town:
Ottobrunn
Phone: 089189454184
Kategorie:
Computer & Software
Typ of Press Release: Kooperation
type of sending: Veröffentlichung
Date of sending: 11.08.2016
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