About EXTEDO
EXTEDO was founded with a simple vision: to help life sciences organizations ensure Effortless Compliance with industry standards and regulatory requirements.
employees
nationalities
customers
in Germany and USA
Our vision
EXTEDO strives to combine industry-leading innovation with compliance and quality with usability. Through our next-generation products and innovations, we enable life science companies to focus on what’s important - delivering high quality medicinal products such as vaccines that improve lives for millions of people worldwide.
It is our mission to help life sciences organizations ensure compliance with industry standards and regulatory requirements. Our Effortless Compliance™ solutions enable agencies, Clinical Research Organizations, and life sciences organizations worldwide to bring new products to market faster and safer.
' opacity='.7'%3E%3Cpath d='M9.3 4.7a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Zm25 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0ZM9.3 29.6a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Zm25 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0ZM9.3 54.5a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Zm25 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Zm-99.7 25a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Zm25 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0ZM9.3 104.2a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Zm25 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.4 0 4.7 4.7 0 0 1 9.4 0Zm24.9 0a4.7 4.7 0 1 1-9.3 0 4.7 4.7 0 0 1 9.3 0Z'/%3E%3C/g%3E%3Cdefs%3E%3CclipPath id='a'%3E%3Cpath fill='white' d='M0 0h109v109H0z'/%3E%3C/clipPath%3E%3C/defs%3E%3C/svg%3E)
Our core values
Management team
Birgit Doblhofer
Vice President Quality and Processes
ISO/IEC 27001 Information Security Management System
- Certification body: TÜV Management Services GmbH
- Valid until: 2025-10-31
- Certificate registration no. 12 310 65902 TMS
- Download certificate: English version, German 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 27001:2017 are fulfilled.
ISO 9001 Certified Quality Management System
- Certification body: TÜV Management Services GmbH
- Valid until: 2025-02-25
- Certificate registration no. 12 100 30723 TMS
- Download certificate: English version, German version
- Details: http://www.tuev-sued.de/ms-zert
The certification body of TÜV SÜD Management Service GmbH certifies that EXTEDO GmbH has established and applies a quality management system for Design, Implementation and Distribution of Document Management Systems, IT-Solutions and associated Services for Life Sciences Organizations.
Proof has been filed that the requirements according to ISO 9001: 2015 are fulfilled.
Microsoft Gold Partner
EXTEDO has renewed its Microsoft Gold Partner status and expanded its Microsoft based eRegulatory Affairs solutions.
“By achieving Gold Certified Partner status EXTEDO has achieved the highest level of the partner program,” said Sandra Schädel, Inside Partner Account Manager Software Partner from Microsoft. “The Microsoft partner program provides software vendors with the right resources to build and support leading edge solutions that take full advantage of Microsoft platform technologies.”
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.
HL7 - Health Level Seven International
Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7's 2,300+ members include approximately 500 corporate members who represent more than 90% of the information systems vendors serving healthcare.
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.
Our Social Engagement
EXTEDO financially supports Médecins sans Frontières, a global movement providing medical assistance to people affected by conflict, epidemics, disasters, or exclusion from healthcare.
It's an EXTEDO tradition to fulfill a tree full of wishes from children living in a local orphanage. We are thankful for all EXTEDO employees who support this great cause.
EXTEDO financially supports the TSV Unterhaching, a local sports club, as well as a local Kindergarden.
.png)