EXTEDO - Key Services and Solutions Provider
Key Services and Solutions Provider
EXTEDO is a key services and solutions provider in the field of regulatory data and document management for life sciences industries and authorities (Pharmaceutical, Crop Science, Chemicals).
Based on industry and regulatory expertise and many years of experience, EXTEDO provides highly standardised as well as customised solutions in the area of electronic regulatory affairs.
EXTEDO is recognised worldwide in each of its engaged business activities. EXTEDO's unique market position provides a tremendous amount of influence on new developments in the e-Regulatory Affairs sector as well as providing long term economic stability.
EXTEDO has designed and implemented the EURS system at EMEA and at various National Competent Authorities. EXTEDO maintains the open standard CADDY.xml for the electronic submission of Crop Sciences applications to support the mission of the ECPA.
EXTEDO being globally represented, serves more than 600 life sciences organisations in more than 50 countries. Within our focus on the life sciences market, we provide services and solutions in the following fields:
•Submission management
•Document management
•Pharmacovigilance management
•Labeling management
•Project management
Submission management
Electronic Submission Management Solutions from EXTEDO support all current standards including CTD, eCTD, PIM, SPL, CADDY and CADDY.xml and the new standard for Study Tagged Files.
EXTEDO's Submission Management Systems can be integrated into standard Document Management Systems as well as Proprietary Systems using common API's.
Document management
EXTEDO's value added Document Management solutions are available for all leading DMS systems from vendors like CSC, d.velop, DOCUMENTUM, FileNet, IBM, Lascom, Microsoft, NextDocs, Open Text, Optimal Systems, Qumas, Saperion and others.
Within extensive national and international projects covering the installation and integration of Document Management Systems inside regulatory departments EXTEDO has acquired both industry expertise and recognition.
Pharmacovigilance management
The Pharmacovigilance solution from EXTEDO was developed as a standardised software solution, especially for the classification, creation, review, submission and maintenance of ICSR, PSUR and SUSAR reports to the EMEA and the National Competent Authorities. This solution has been designed to be fully functional with minimal software requirements.
EXTEDO's standardised software solution is a high-quality, user friendly product for the straightforward drug safety management based on the MedDRA and E2B standards.
Labeling management
The labeling management solution from EXTEDO provides native authoring for PIM labeling information. The solution is fully integrated with eCTDmanager and translation systems like TRADOS. Finalised PIM and SPL submissions are added when appropriate to the eCTD with a simple "drag and drop" operation.
EXTEDO's standardised software solution offers benefits like rule sets for editing QRD templates, managing of country specific translations, support of the general translation process, validation, export and publishing of the submission as well as import of reviewed submissions from the authorities.
EXTEDO GmbH
Einsteinstraße 30
85521 Ottobrunn
Germany
Tel: +49 89 189454 0
Fax: +49 89 189454 999
Email: info@extedo.com
URL: www.extedo.com
EXTEDO Ltd.
Concorde House, Trinity Park
Solihull, Birmingham B37 7UQ
UK
Tel: +44(121) 6355175
Email: info@extedo.co.uk
EXTEDO Inc.
(North America)
770 E.Market St.,STE 115
West Chester, PA 19382
USA
Tel: +1(484)881-3124
Toll free: +1(877)ESUBMISSIONS
Fax: +1(215)701-6570
Email: info@extedo.us
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