Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will […]
What’s next after eCTD? Read More »
We are proud to announce our new partnership with DACHS to meet the growing needs for document conversion & enrichment in the Life Sciences industry. The advanced content conversion capabilities of DocShifter combined with the expertise of DACHS in document management for pharmaceutical companies make a powerful strategic alliance.
DocShifter proudly announces its exciting new partnership with Generis Knowledge Management Inc. to provide industry-leading rendition handling as part of their CARA toolsuite. The advanced content conversion abilities of DocShifter, together with the functionality in CARA and the resulting application will provide complete compliance functionality for regulated content management use cases, especially for Life Sciences.
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The volume of digital information is increasing at warp-time speed. Whether created as a result of the digitising of non-digital collections, as a digital publication or artwork, or as an inherent part of the day-to-day business of an organisation or individual, more and more information is being created digitally and the pace at which it
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In recent years, the Life Sciences industry has been moving regulatory activities from paper based processes to fully digital. During this shift, they are facing enormous challenges to comply with the increasingly complex regulatory environment as more and more of the world adopts the fully electronic eCTD submission and other fully electronic formats.
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Our partner Strator helps companies with everything to do with documents, with a wide range of hand-picked technologies, deep business understanding and long experience. They work in any industry but Life Sciences is by far their most dominating market and experience.
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The electronic submission requirements (CDER/CBER) will apply to the following types of submissions:
Frequently asked questions on the eCTD format (Part 2) Read More »
This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: review notification or in response to a request for additional information What are the
Frequently asked questions on the eCTD submission format (Part 1) Read More »
CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.
A closer look into the eCTD triangle and its modules Read More »
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