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CMC: Authoring & Publishing Automation – Challenges/Solutions

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At the high-impact R&D end of life sciences, investment in technology is consciously linked to commercial priorities including innovation, efficiency and speed to market. Here, smart use of te…
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Current labeling compliance risks mitigation actions

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When it comes to labeling compliance, historically, BioPharma could argue that they simply did not have the information available to identify potential compliance dissonance across their business …
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Time to Free the Regulatory Middle Manager

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The shift to remote work has taken its toll on us all, but middle managers have faced particular challenges over the last year. A global survey of over 3,000 remote knowledge workers found that mi…
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Current Alternatives To EUDAMED

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The launch of EUDAMED for May 2022, which correlates with the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). In this regard, the official launch of …
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Labeling Localization, Reusability and Translation Cost Reduction

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It has long been known that converting documents and content to a digital foundation structure can improve efficiency, save time and reduce translation costs due to content reuse and automation. M…
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