Category: Blog

AI-Driven CMC Excellence with Structured Content Management

AI-Powered Structured Content Management: CMC Excellence Exploring the convergence of AI and structured content management (SCM) in Chemistry Manufacturing and Controls (CMC) Module 3 offers a profound shift in pharmaceutical documentation.  This blog unveils the impact of AI-powered structured content management on CMC outputs, emphasizing efficiency, compliance, and innovation. We will delve into the significance […]

Written by on February 22, 2024

ePI: The Future of Pharmaceutical Labeling has Arrived

Abstract The pharmaceutical industry lags other major industries in terms of how critical information is relayed to patients ; continued reliance on printed, paper-based instructions to inform patients of when and how to use medications makes little sense in our digital world. Further, existing pharmaceutical labels are widely considered to be overly complex and inaccessible […]

Written by on January 2, 2024

Using AI to Improve Clarity & Readability of Drug Labels

The readability of pharmaceutical labels is a growing problem, particularly in regions with aging populations where drug consumption is growing rapidly (to the tune of a 3-6% CAGR).[1] In the United States, for example, drug labels have been criticized for being overly complex and difficult to read; each year, over a million Americans experience a health […]

Written by on November 16, 2023

Top 4 Benefits of AI-Powered Labeling

Given the transformative potential of Artificial Intelligence (AI), pharmaceutical companies need to plan for a future in which this technology is routinely used in the drug development and marketing lifecycle. In this post, we break down the four biggest benefits of AI-powered drug labeling.

Written by on November 1, 2023

Redefining Content Management with CCMS

Component content management systems (CCMS) sit at the heart of an SCM strategy and enable content management at a more granular level. It meticulously organizes and manages content as components rather than documents, creating modular and reusable chunks of content that become interchangeable building blocks for various documents and submissions.

Written by on September 27, 2023

Enhancing Compliance & Efficiency with Structured Content Authoring

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 […]

Written by on June 28, 2023

Accelerating Pharmaceutical Labeling Processes: The Power of AI and ML Technology

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 […]

Written by on April 26, 2023

Structured, XML-Based Authoring Made Easy

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 […]

Written by on March 16, 2023

Achieving Content Compliance Success in Life Sciences

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 […]

Written by on November 16, 2022