In the fast-paced and highly regulated pharmaceutical industry, the efficient management of labeling and regulatory submissions is crucial for ensuring compliance, patient safety, and the fast and successful market entry of innovative drugs. However, this process comes with its fair share of challenges. From navigating Chemistry, Manufacturing, and Controls (CMC) regulatory requirements to addressing global […]

The Need for Speed and Efficiency in Pharmaceutical Labeling Pharmaceutical innovators understand the value of being the first to market with novel medicines. First movers often make important contributions to human health and achieve superior financial returns for distribution to shareholders and reinvestment in product development than fast followers. The most competitive and innovative pharmaceutical […]

Whether in client meetings, conferences like DIA, or during participation in Gartner, Navitas, or Forrester special interest groups, there is always a buzz about Microsoft Word and the challenges it presents to structured content. In support of XML structured content authoring at the component level, there needs to be an integration with a tool to […]

AI’s Impact Across Industries From finance to football, Artificial Intelligence (AI) is seeping its way into nearly every industry you can think of. Whether you’re looking for an AI tool to author a children’s book in under 5 seconds or to auto-generate futuristic portraits of yourself, AI can do it all. With all this newfound […]

I was pleased to be a guest speaker at the third episode of Quark’s “Close the Content Loop” webinar series, called How Do Life Sciences Companies Keep Content Compliant?, where we discussed the importance of content compliance among life sciences organizations. When talking about content management for content compliance in the life sciences industry, we’re […]

TL;DR Enterprise IT projects can generally be broken into two groups: 1. daily run-of-the-business – IT operations and infrastructure activities and 2. change initiatives. On average, two-thirds of overall enterprise IT spending goes towards infrastructure and operation. A clear and coherent change agenda will reduce waste by eliminating failed, delayed, and misaligned projects. Shifting investments […]

TL;DR SmPC is a legal document used by healthcare professionals that provides information on the drug including the set dosage and other key information. Even with strict regulation with rigorous guidelines and structure for the information contained in SmPC, too often information has been found incomplete.  Major gaps have been discovered in the information on […]

Overview Living in an environment that is fully FAIR means you spend less time on tedious tasks. When your data hits the Findable principle, it’s like doing a Google search and the results you are presented with are exactly what you want. Because data in life sciences companies can exist across many tools, systems and […]

What is Structured vs. Unstructured Data? TL;DR Structured data is predefined, in a set format that can be easily searched by machines.  Unstructured data is undefined and can be in various formats like text, images, audio, and video files.  Unstructured data makes up 80% of data. 63-70% of enterprise data goes unused. Natural Language Processing […]

TL;DR Structured Product Labeling (SPL) is the FDA’s approved standard for communicating product and quality information. SPL is based on XML. If managed well, SPL is easily maintained even if there are many changes to a drugs product information. What is Structured Product Labeling? Structured Product Labeling (SPL) is the FDA’s adopted standard for communicating […]