March 24, 2011 08:44 ET

EXTEDO Helps Facilitate Expansion of the eCTD Market in Eastern Europe by Sponsoring Regulatory Workshop in Slovenia

MUNICH, GERMANY and OTTOBRUNN, GERMANY--(Marketwire - March 24, 2011) -  EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that it will intensify its sales and support efforts in Southeast Europe.

"Croatia's authority HALMED was the region's first authority using EURS is Yours, EXTEDO's solution for reviewing electronic submissions, and published its eCTD specification in the summer 2010. The first workshop about eSubmissions in Slovenia now confirms the growing significance of electronic submissions for the whole region. It is quite evident that the region is preparing to embrace eSubmissions and we will actively support this development with our broad experience in e-regulatory affairs," said Christian Bohrmann, Vice President of Global Sales and Marketing for EXTEDO.

An open dialogue between all parties is crucial for electronic submissions to be successful in the region. The "1st Regional Regulatory Workshop: Electronic Submissions" taking place in Kranjska Gora, Slovenia, 31 March to 1 April 2011, is the perfect venue to establish the necessary regional network and discuss how a seamless digital cooperation between authorities and industry can benefit the region. EXTEDO will demonstrate eCTDmanager, the compilation tool for electronic submissions, at this event. The workshop is specifically designed for regulatory affairs executives who work in the life sciences industry.

"We work closely with key regulatory authorities around the world to make sure that all of the products in the EXTEDOsuite fully support the latest standards," stated Tore Bergsteiner, CEO for EXTEDO. "The version of the EURS is YOURS product that is available today fully supports the HALMED eCTD and NeeS standards."


EXTEDO is the key solutions and services provider in the field of eRegulatory Affairs. The complete EXTEDOsuite is unique in all that it covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Label Management, and Document Management.

EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.

Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare, and public sector. EXTEDO is recognized as the worldwide leader in each of its areas of operation.

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