SOURCE: EXTEDO

February 06, 2012 08:00 ET

EXTEDO Hosting EURS Experts Forum 2012 in Germany

Officials From Over 15 European Regulatory Agencies Will Be Attending

OTTOBRUNN, GERMANY--(Marketwire - Feb 6, 2012) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced it will be hosting the EURS Experts Forum 2012 in Munich, Germany, on February 7-8, 2012. The EURS Experts Forum 2012 provides more than 25 officials from different agencies with a unique opportunity to discuss new ways to manage and validate regulatory submissions, as well as learn from their peers on how to best leverage the EURS is Yours software solution.

Officials from over 15 different European regulatory agencies and organizations will be attending the event, including representatives from the European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), The European Agency for the Medical Products Agency (MPA), and The Telematics Implementation Group for Electronic Submission and ICH Implementation (TIGes).

EURS is Yours is part of the EXTEDOsuite that serves as an overall eCTD & NeeS format validation and reviewing software tool. It reports whether a submitted eCTD- or NeeS-based application conforms to the official eCTD or NeeS format.

EURS is Yours is especially designed for the validation, acceptance, import, review and maintenance requirements of the EMA (European Medicines Agency), the associated national competent authorities (NCAs), as well as authorities outside of the European Union, including Swissmedic, Saudi FDA, and Croatian HALMED.

About EXTEDO

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling 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 one of the worldwide leaders in each of its areas of operation.

For more information visit www.extedo.com.

All trade names, trademarks, and service marks are the rightful property of their respective owners.

Contact Information

  • Media Contact:
    Michael Kane
    EXTEDO
    Tel: 1-978-257-2179
    Email: Email Contact