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Qdoor B.V.

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Launch of New eCTD Viewer: Viewing Matters for eCTD, NeeS and Other Regulatory Dossier Formats

Den Bosch, Netherlands, August 02, 2017 --( Qdoor B.V. released Dossplorer; a new regulatory dossier viewer for the purpose of viewing eCTD, NeeS and other regulatory dossier formats. The software is now available for a free trial with pre-loaded demo dossiers or as a paid version for exploring your own dossiers.

Dossplorer is an eCTD viewer and NeeS viewer but also supports viewing any file and folder structure. This allows life science companies to import all their dossiers in one place, including applications in formats like Investigational Medicinal Product Dossiers (IMPDs), electronic Clinical Trial Applications (eCTAs) and Medical Device dossiers.

In addition to traditional views on eCTDs, the software offers unique views across regulatory dossiers. Dossplorer can merge multiple dossier branches (for example multiple 3.2.P Drug Product sections for different dosage forms or strengths) into a single section. Furthermore, Dossplorer can consolidate information from multiple products or countries into a single module 1 to 5 structure. This enables viewers to create a holistic view on their dossiers; easily compare contents from different products or countries and eliminate the need to switch between multiple applications.

“Often companies tend to focus more on the publishing aspects of their regulatory applications, but we believe that viewing matters. With Dossplorer we allow them to unlock and explore the true value of their regulatory dossiers in a safe and secure, web-based dossier viewer,” said Michiel Stam, Product Manager of Dossplorer. “We have the technical knowledge and regulatory experience required to create views which add real business value.”

The hybrid-cloud solution offers the advantages of a cloud-based application whilst keeping the data privately and safely stored on premise. The monthly charge by credits allows occasional viewers of eCTDs to make economical use the software, without the need to purchase an annual named user license.

About Qdoor B.V. and Dossplorer

Qdoor B.V. is a software company for life sciences founded in 2016 by Hans van Bruggen, Director and senior Regulatory Affairs Consultant. The Company’s mission is to facilitate optimal reusability and consistency in document management across regulatory dossiers by creating transparency. This requires both technical and regulatory knowledge. The Dossplorer viewer is designed and tested by regulatory affairs & operations professionals with many years of practical experience in the pharmaceutical industry. To learn more about Dossplorer, visit the Dossplorer website
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Qdoor B.V.
Evelien Vink

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