About EXTEDO
Over two decades of service
Our long history of success within the life science industry has resulted in our services and software solutions helping more than 1000 customers in 65 countries to achieve Effortless Compliance™.
EXTEDO has also become the trusted solution provider for regulatory authorities such as the European Medicines Agency, most local European National Competent Authorities, Swissmedic, and other regulatory agencies worldwide. With innovation and openness being part of our culture, many of our team also play leading roles within local standards committees and the ISO group, defining standards worldwide.
Since February 2024, EXTEDO is part of Bertelsmann Group. Becoming part of Bertelsmanns’ Digital Health division marks a significant milestone in advancing operational excellence. This acquisition presents a fantastic opportunity for EXTEDO to expand our global footprint further and enhance synergies within the Bertelsmann Group, enabling us to better meet the future needs of global life sciences organizations, regulators, and patients.
Our core values
Management team
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Martin Schmid
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Françoise Brodkorb
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Schei Dattner
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Birgit Doblhofer
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Ina Glaser
Dr. Stavros Kardahakis
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Dr. Gerhard Neurauter
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Hans-Ulrich Seufert
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Martina Steckenleiter
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Keith Wallace
Certifications and memberships
ISO/IEC 27001 Information Security Management System
- Certification body: TÜV Management Services GmbH
- Valid until: 2026-06-06
- Certificate registration no. 12 310 65902 TMS
- Download certificate: English version
- Details: http://www.tuvsud.com/ms-zert
The certification body of TÜV SÜD Management Service GmbH certifies that EXTEDO GmbH has established and applies an Information Security Management System according to “Statement of Applicability” for Conception and operations of IT solutions for the life sciences industry.
Proof has been filed that the requirements according to ISO 27001:2022 are fulfilled.
ISO 9001-2015 Certified Quality Management System
- Certification body: TÜV Management Services GmbH
- Valid until: 2028-02-25
- Certificate registration no. 12 100 30723 TMS
- Download certificate: English version
- Details: http://www.tuev-sued.de/ms-zert
The Certification Body of TÜV SÜD Management Service GmbH certifies that the organization Bertelsmann SE & Co. KGaA represented by EXTEDO GmbH and including the sites EXTEDO Inc. and EXTEDO Croatia d.o.o., has established and applies a Quality Management System for the scope "Design, Implementation and Distribution of Document Management Systems, IT-Solutions and associated Services for Life Sciences Organizations". An audit was performed at EXTEDO GmbH, EXTEDO Inc. and EXTEDO Croatia d.o.o. and has furnished proof that the requirements according to DIN EN ISO 9001:2015 are fulfilled.
BPI - Bundesverband der Pharmazeutischen Industrie e.V.
EXTEDO is member of the BPI, a nationally and internationally acting industrial association (based in Germany) with 240 organisations and ca. 70,000 members of the pharmaceutical industry. BPI's aim is a continuous enhancement of the public health sector.
DIA - Drug Information Association
DIA is a neutral, global, nonprofit association that provides knowledge resources across the full spectrum of medical product development.
DIA provides professionals at all levels and across all disciplines access to timely and authoritative information to advance careers, skills, and innovation in the pharmaceutical, biotechnology, medical device, and related fields. DIA is a neutral forum for facilitating knowledge exchange.
IRISS - Implementation of Regulatory Information Submission Standards
The mission of IRISS is to enable successful implementation and practical usage of a paperless regulatory submissions environment which supports current regulatory processes and enables efficient and effective assembly, review and maintenance of required regulatory information in support of clinical trial applications and marketing applications around the globe. The current ICH eCTD specifications are the cornerstone of this effort, but other electronic regulatory submission standards, such as CDISC and HL7 standards are also in scope.
MEGRA - MittelEuropäische Gesellschaft für Regulatory Affairs e.V.
MEGRA e.V., the middle-European Association for Regulatory Affairs, is an association of experts from mainly German-speaking countries, who are working in a regulated environment of medicines, medical devices and similar areas.
Gravitate Health Open E2E ePI Community
The Gravitate-Health Open End-to-End (E2E) ePI Community is an open, collaborative initiative dedicated to transforming the electronic Product Information (ePI) lifecycle—from early development and regulatory submission to post-marketing use. The community aims to advance the structuring, accessibility, and exchange of medicinal product information by promoting an E2E dataflow approach.
By supporting innovation, aligning with European pharmaceutical legislation, and enhancing patient access to reliable information, the community contributes to improved health literacy, patient safety, and sustainability.
Founded by Gravitate-Health and cormeo (Docuvera, EXTEDO, and Rote Liste), the E2E ePI Community serves as a catalyst for change across the healthcare and regulatory ecosystem.
https://www.gravitatehealth.eu/gravitate-health-open-e2e-epi-community/
