With the introduction of new cutting-edge therapeutic modalities like immunotherapies and cell and gene therapies, the process of pharmaceutical labeling has grown increasingly complex. To analyze medicinal product submissions more effectively, health authorities are exploring ways to accept additional data submissions rather than depending primarily on previous document submissions.

As a result, pharmaceutical companies are turning to technology solutions for support with their end-to-end regulatory strategy. They are seeking assistance in overcoming a variety of challenges, including the management of drug assets in various stages and resource limitations. For the many steps within the labeling process, multinational biopharmaceutical companies frequently use a range of loosely connected technologies. This strategy is ineffective, difficult to comply with and report on, and restricts the capacity to reuse or repurpose content – especially on a global scale.

Technology may assist with drug labeling

In addition, drug labels are constantly changing, with hundreds of new or revised labels being released every week across various countries. Searching through diverse data sources and languages for pertinent data points and insights takes a great amount of time and effort on the part of labeling teams. To achieve compliance with laws and put patient safety first, pharmaceutical companies must manage labeling effectively.

If companies are looking to enhance their labeling efforts without increasing the manual burden of label intelligence and creation, they need to utilize innovative technologies.  A unified, end-to-end label technology solution can help both large and small life science companies track and distribute new data to the proper audience, providing real-time accurate labeling information to labeling teams and healthcare providers as soon as a product change is approved by regulators.

Scalable top-layer technology can unify and support the current labeling procedure across all available solutions, while intelligence automation (IA) and natural language processing (NLP) capabilities can help with regulatory intelligence during labeling change assessments as well as on-demand contextual translations. For life science organizations, switching from document-centric regulatory submissions to data-centric component-based perspective is an critical adjustment. Technology can help them evolve to operate effectively in a new “real-time information accessible” paradigm. Component management can be used to integrate internal and external regulatory intelligence and changes, highlight impacts for labeling, and enable companies to compile label changes or submissions from the individual pieces needed to create each document. This can then leverage innovative technologies such as structured content authoring (SCA) to reduce manual efforts.

Smart labeling solves regulatory labeling challenges

To manage worldwide pharmaceutical labeling more effectively, smart labeling solutions need to integrate various unconnected technologies into a single platform and offer access to appropriate content management. In the case of the IQVIA RIM Smart Labeling unified application, IQVIA's domain expertise is paired with the essential technology, tools and services. The system orchestrates regulatory compliance and promotes efficiency while improving content tracking, planning and implementation.

By combining various separate technologies into a single, tightly knit platform, the IQVIA RIM Smart Labeling solution is a purpose-built, next-generation label information management solution that streamlines the labeling process. Biopharmaceutical companies can gain from this solution in several ways, including increased upstream and downstream visibility, the consolidation and orchestration of local and international labeling operations, lower technology costs due to the elimination of legacy systems and multiple vendors, seamless integration within the current technological ecosystem, and more. Users of RIM Smart Labeling have total control over request intake, planning and execution, label content creation, translation/artwork alignment, submission tracking and implementation reporting via a single activity dashboard that displays information on workflow, notifications, alerts and metrics.

To increase efficiency, IQVIA offers customer services that integrate seamlessly with current technology and directly with the systems currently in place. The Labeling Intelligence Hub is one such powerful solution offered by IQVIA. This solution simplifies the process of finding and extracting drug label information from diverse sources such as the FDA, EMA, France, Spain. With the help of IQVIA's NLP technology to enable effective search, users can extract maximum value from each label faster and more accurately than ever before. The solution also allows users to build their own label searches or deploy pre-built searches to optimize their label writing and analytics.

With integrated regulatory intelligence capabilities, our proven solutions – RIM Smart Labeling and the Labeling Intelligence Hub – can further operationalize and boost efficiency in the labeling process. Pharmaceutical businesses will expedite their labeling processes and effectively traverse the complicated regulatory landscape with the help of IQVIA's experience and solutions.

If you want to learn more about RIM Smart Labeling and IQVIA’s Labeling Intelligence Hub for your end-to-end regulatory strategy, check out the webinar here. To speak with an expert, send a note to regulatorytechnology@iqvia.com.