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CMC: Authoring & Publishing Automation – Challenges/Solutions

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…

Current labeling compliance risks mitigation actions

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 …

Time to Free the Regulatory Middle Manager

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…

Current Alternatives To EUDAMED

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 …

Labeling Localization, Reusability and Translation Cost Reduction

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…