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EXTEDO

For nearly 15 years EXTEDO has been 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 well-founded expertise and many years of experience EXTEDO provides highly standardized as well as customized solutions in the area of electronic Regulatory Affairs.

EXTEDO is a worldwide recognized partner in each of its engaged business activities. EXTEDO’s unique market position provides a tremendous amount of inspiring influence on future-oriented new developments in the e-Regulatory Affairs sector and economic long term 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, services more than 600 Life Sciences organizations 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 like CTD, eCTD, PIM, SPL, CADDY and CADDY.xml including the new standard regarding Study Tagged Files.

EXTEDO’s Submission Management Systems can be integrated into standard Document Management Systems as well as Company Internal Systems via common available API’s.


Document management

EXTEDO's value added Document Management solutions are generally based on 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 regarding the installation and integration of DMS inside regulatory departments EXTEDO has acquired a well-founded expertise and recognition.


Pharmacovigilance management

The Pharmacovigilance solution from EXTEDO is developed as a standardized 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 elementary software.

EXTEDO’s standardized software solution is a high-quality and functional 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 and SPL labeling information. The solution is fully integrated with eCTDmanager and some Translation Memory Systems like TRADOS. Finalized PIM and SPL submissions are added when appropriate to the eCTD with a single and simple “drag and drop” operation.

EXTEDO’s standardized software solution offers benefits like rule sets for editing QRD templates, managing of country specific translations, support of general translation process, validation, export and publishing of the submission as well as import of reviewed submissions from the authorities.

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