EXTEDO's Certifications & Memberships

As one of the leaders in regulatory solutions, EXTEDO has acquired a wide range of certifications, as well as being part of numerous organizations.

Certificates

ISO 9001 Certified Quality Management System

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.”

EXTEDO MPDmanager: BEST OF 2015 Industry Solutions

In a contest of "Innovationspreis-IT der Initiative Mittelstand" (a German award for IT innovations of SMEs), under the patronage of Microsoft, EXTEDO MPDmanager 2014 was picked out of about 5000 applicants to be one of the best solutions in the field "industry solutions" (top 10).

Memberships

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. 

http://www.bpi.de/

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. 

http://www.diahome.org

DIN - Deutsches Institut für Normung e. V.

Christine Hirt, Managing Consultant at EXTEDO, has been nominated as the German delegate for the DIN (Deutsches Institut für Normung). Christine works in the Working Group WG6 (Pharmacy) for the ISO IDMP standard (ISO = International Organization for Standardization, IDMP = Identification of Medicinal Products).

Standards Committee: NA 063-07-03 AA – Normenausschuss Medizin (NaMed) 

EXTEDO is part of the ISO IDMP standardization process of medicinal products for human use. 

http://www.din.de

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. 

http://www.hl7.org/

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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 ofclinical trial applications and marketing applications around the globe. The current ICH eCTD specifications is the cornerstone of this effort, but other electronic regultory submission standards, such as CDISC and HL7 standards are also in scope. 

http://www.iriss-forum.org

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 an regulated environment of medicines, medical devices and similar areas. 

http://www.megra.org/ 

SNV - Schweizer Normen Vereinigung (Swiss Association for Standardization)

Christian Kravogel is member of the SNV, a provider of information services driven by the future. The SNV defends the interests of business and society in Switzerland and works for their benefit. 

http://www.snv.ch/ 

*IRISS and the IRISS Logo are trademarks of IRISS. Their use indicates the organization is a member of IRISS, but does not imply endorsement or certification of products and services. The same applys for the other logos/associations shown on the "Memberships" section of this page.

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