Changing Landscape of Regulatory Information Management in the Pharmaceutical Industry


Regulatory data is vital for running a pharmaceutical company as it provides critical information for manufacturing and R&D document authoring processes. With the increased pressure to manage regulatory information more efficiently and with high data quality, the Pharma industry is being forced to adopt next-generation information management systems that can scale up and manage regulatory information in this dynamic landscape.

This blog will examine some of the difficulties involved in drug regulatory information management. It will also look at solutions to improve these departments’ efficiency and regulatory compliance.

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Challenges Facing the Pharmaceutical Industry

It is no surprise that pharma companies are struggling with streamlining the regulatory information management (RIM) framework. The pharma industry faces many challenges, such as the high cost of drug development, mounting pricing pressure, and the need to expand into new global markets. Process dependencies, iterations, and rework have added to the inefficiency of the processes and resulted in delayed submissions and, in turn, a late market launch for drugs.

This increases the importance, complexity, and risk of managing regulatory information assets. Many departments use regulatory documents within the enterprise for business development, marketing, labelling, supply release, local affiliate tracking, and third-party information exchange and collaboration. Companies are greatly hampered without a holistic view of regulatory information management as an enterprise-wide process.

Regulatory affairs services professionals need to be able to see important information that is too often cut off from them in data and document silos that are local and departmental. This affects their ability to comply with regulations and operate efficiently and harms their strategic planning skills, productivity, and sense of innovation.

Solutions for Growth and Modernization of RIM

Based on the pharma companies’ business and IT strategies, budgets, and leadership buy-in, different firms are focusing on and adopting varied phased approaches to make RIM more efficient. The current focus is on transforming the regulatory information management landscape by integrating the various silos into a single, consolidated platform.

The goal is to make the systems simple and flexible enough to work together and provide a comprehensive view of regulatory information. This will help identify compliance needs while making the process efficient, productive, and transparent.

As the life sciences industry continues to enter the realm of automation and artificial intelligence, more information will emerge. AI-powered tools for RIM can support pharma companies to manage regulatory documents, including those for electronic submissions, more efficiently and effectively.

Pharmaceutical companies grapple with large volumes of data and various data sets. Thus, the need for simplified, secured, integrated, interoperable platforms is growing. Pharma companies must ensure innovative technologies are in place, automatic data integration is possible, and metadata management is simple and effective.

In addition to the increased popularity of collaborations, data sharing, and better decision-making, pharma companies are also beginning to adopt agile and DevOps practices for faster and more efficient delivery.

Furthermore, they are exploring and leveraging various options to modernize and transform their RIM processes. The key is leveraging this data and automation technology to drive greater efficiencies in the regulatory process and enable the regulatory teams to focus on higher-level strategic projects.

The Changing Landscape in Pharma

Regulatory strategists and operations professionals can benefit from an information management approach that combines comprehensive global regulatory information into one role-based view. Life science companies that make the most of organizational information across all operations, including R&D, submissions, labelling, and marketing, have a strategic advantage.

A regulatory information management system is necessary to help regulatory professionals to keep track of complex global regulatory data and processes. This would include correspondence, commitments, approvals, and management. With this system in place, the RP can better plan, coordinate and execute their pharmaceutical regulatory affairs. As a result, they would be able to achieve superior compliance.

We need to change how RPs currently manage and organize their regulatory information. A new system that helps regulatory affairs services personnel track and manages complicated global regulatory data and processes is the need of the hour.

Additionally, this will help reduce the risk of regulatory non-compliance, improve communication between different departments within the RP, and optimize workflows.

For example, the RP can monitor all current and upcoming obligations to health authorities to ensure that your company meets requirements. The RP can also develop a system to keep track of potential risks and investigate possible solutions.

Filing plan functionality can help eliminate the need for constant monitoring of submissions by coordinating multiple contributors in a timely way throughout the workflow. RPs resources can be deployed to more value-added activities with such efficiency gains.

Summing Up

The pharmaceutical industry is very regulated, and regulatory information is considered a strategic asset. How these companies store, share, access, and leverage this information is changing. Peeling back the layers, we see that regulatory information management is more than just a process, but rather a technology platform that can transform internal and external business processes, improve collaboration and ultimately drive innovation.

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