Each year, Life Sciences companies produce and manage large quantities of regulatory and patient-facing content. To meet compliance standards, ensure patient safety, mitigate risks, and reduce go-to-market cycle times, pharmaceutical companies are continually looking for new technologies and processes to streamline workflows, reduce complexity, and reuse content efficiently. One such technology that has been making waves […]

HL7[1] accelerator Vulcan[2] recently published an implementation guide for FHIR, an interoperability standard intended to facilitate the exchange of healthcare information across the ecosystem. Shortly after, the European Medicines Agency (EMA) announced that it would begin accepting FHIR outputs on a trial basis; other health authorities, including the FDA, are likely to follow suit.[3] The inevitable […]

Product recalls in the life sciences industry are not rare. In Q1 2018 alone, for example, 84 pharmaceutical companies in the U.S. reported at least one recall.[1] While these recalls are often attributed to defective or potentially harmful drugs (such was the case in the infamous 1982 recall of 31 million bottles of Tylenol tainted […]

Generative AI, a subset of artificial intelligence that analyzes large volumes of data to create text, images, and other outputs, is quickly becoming a disruptive force in the life sciences industry. For example, this purpose-built technology is employed to accelerate drug discovery, improve clinical trial planning and execution, decrease drug recalls, and lead to more […]

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 of CMC outputs, the synergy of SCM […]

The pharmaceutical industry lags behind 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. Existing pharmaceutical labels are widely considered to be overly complex and inaccessible across patient […]

Pharmaceutical labels are often complex and riddled with medical jargon, making them difficult for patients to completely understand. AI is helping pharmaceutical companies mitigate this challenge so that patients gain clarity on their medications. In this post, we discuss the top 3 ways AI is revolutionizing pharmaceutical labels to enhance patient comprehension. The readability of […]

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.

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.

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 […]