EXTEDO - Key Services and Solutions Provider in eRegulatory Affairs

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 and tracking
• Submission management, (eCTD, CTD, NeeS, CADDY, ePRISM, eIndex, eNTA , vNeeS)
• Pharmacovigilance management (SUSAR, ICSR, PSUR, E2B)
• Labeling management (PIM, SPL)
• Document management

We provide configurable off-the-shelf products, as well as customised 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 we serve more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organisations. 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

Product registration planning and tracking

DRAmanager ensures the fast and smooth functioning of creating and maintaining product and device information and associated activities in accordance with the pharmaceutical, medical and health-related government and regulatory bodies around the world.

Submission management

Electronic submission management solutions from EXTEDO support all current standards like on CTD, eCTD, NeeS, IMPD, CTA, eNTA, VNeeS, CADDY, CADDY.xml, e-PRISM, e-Index and other submission structures. EXTEDO's submission management systems can be integrated into standard document management systems as well as proprietary systems using common APIs.

Pharmacovigilance management

PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables you to classify, create, review, submit, and maintain Pharmacovigilance data and adverse event reports.

Labeling management

The labeling management solution from EXTEDO is a standardised and open software solution for the creation, review, translation, maintenance and submission of electronic labeling documents, including Company Core Data Sheets (CCDS),and PIM files. It supports internal, as well as integrated, translation and drug approval processes with the EMA.

Document management

EXTEDO's value added document management integrations are available for all leading document management Systems (DMS):

• EMC Documentum™
• NextDocs™
• CSC FirstDoc™, CSC FirstPoint™
• OpenText™
• IBM SCORE™
• Optimal Systems™
• MasterControl™
• QUMAS DocCompliance™
• Microsoft SharePoint™
• and others

Within extensive national and international projects covering the installation and integration of document management systems within regulatory departments EXTEDO has acquired both industry expertise and recognition.

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