EXTEDO, a leading provider of Regulatory Information Management solutions, today announced the integration of eCTDmanager, their proprietary electronic submissions management solution, with MasterControl.

Through the new MasterControl DMS Connector for eCTDmanager, life sciences firms can optimize their processes for creating and maintaining compliant submissions in eCTD, NeeS, eCopy, IMPD, CTA, PIP, VNeeS, DMF, ASMF and other regional formats. It enables them to readily view, review, compile, and publish submissions that contain documents managed within MasterControl repositories.

“There is a clear trend toward using cloud-based solutions in the life sciences industry,” said Maximilian Munte, Managing Director at EXTEDO. “We are pleased to be able to allow our customers to choose between on-premise and cloud for both eSubmission management and DMS solutions.”

Using the MasterControl DMS Connector, users simply drag-and-drop documents directly into sequences. They are also able to view metadata and manage versions without the need to leave the eCTDmanager environment. With only a single interface to navigate, the time to create and publish valid submissions is significantly reduced. It also ensures consistency and reduces the expense associated with regulatory compliance.

“We are excited to expand our partnership with EXTEDO with this integration between MasterControl and eCTDmanager.  This integration will provide our mutual customers a more seamless experience between submission content management and submission publishing,” said Brian Curran, SVP of Strategic Growth at MasterControl.

About MasterControl

Founded in 1993, MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.

Über die EXTEDO GmbH

EXTEDO is a leading software and solutions provider within the field of Regulatory Information Management (RIM). EXTEDO focuses on optimizing clients‘ eRegulatory business processes, and their EXTEDOsuite provides tools to support the complete regulatory landscape.

EXTEDO develops configurable off-the-shelf products, as well as customized and integrated solutions compliant with Medical Product Dictionary. EXTEDO also provides EURS, the validation, review and approval software solution used by the EMA and over 30 Regulatory Authorities worldwide.

Today EXTEDO serves more than 850 customers in 60 countries, ranging from small companies to large multinational organizations. EXTEDO supports many disciplines within life sciences area, including: pharmaceutical, biotech and biopharma, generics, homeopathics, medical devices, crop sciences and public sector. EXTEDO is recognized as one of the worldwide leaders in each of these areas.

For more information visit http://www.extedo.com/.

Firmenkontakt und Herausgeber der Meldung:

EXTEDO GmbH
Einsteinstrasse 30
85521 Ottobrunn
Telefon: +49 (89) 189454-0
Telefax: +49 (89) 189454-999
http://www.extedo.com

Ansprechpartner:
Ina Scharfen
Marketing Manager
Telefon: +49 (89) 189454-139
Fax: +49 (89) 189454-980
E-Mail: scharfen@extedo.com
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