Munich / Ottobrunn, Germany – August 26, 2015 – EXTEDO, a leading eRegulatory Affairs solutions provider to life sciences firms, announced today its plan for the support of the Australian eCTD submission specifications within its eCTDmanager, EURS and EURSvalidator products from Q4 2015:
- eCTDmanager is an easy-to-use solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.
- EURS (EXTEDO Universal Review System, formerly called EURS is Yours) is the eCTD validation and reviewing software tool used by more than 30 regulatory 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 Christian Bohrmann, VP Marketing & Alliances at EXTEDO. “The EXTEDOsuite is designed to be easy-to-use and deploy, allowing organizations of any size to be developing compliant and robust e-submissions within a very short period.”
To provide local support and regulatory consulting services to Australian customers EXTEDO will be working together with regional regulatory specialists Bio and Gene. With this Partnership EXTEDO is expanding its global reach and will be able to provide support in all time zones.
About Bio and Gene
Bio and Gene Pty Ltd is a privately owned, Australian biotechnology company established in 2002 with a view to assist Asia Pacific companies commercialize their health and pharmaceutical products within Australia’s robust regulatory framework.
Bio and Gene boasts a proven track record of success thanks to the validation and support of quality clinical data and recognized regulatory agencies.
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 life sciences area, including: pharmaceutical, biotech and biopharma, generics, homeopathics, medical devices, crop sciences and public sector. EXTEDO is recognized as one of the worldwide leaders in each of these areas.
For more information visit http://www.extedo.com/.
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