Digital transformation of global pharmaceutical regulatory teams: Three benefits of a centralized solution

As the global pharmaceutical regulatory environment continues to change, pharmaceutical companies must constantly adjust their strategies to ensure compliance with relevant regulations. Regulatory teams have gradually integrated digital technologies into their workflows. Although this transformation has brought many new challenges and complexities, it has also helped teams accelerate submissions, improve collaboration efficiency, and increase transparency at all stages of the entire regulatory process. For example, the impact of China's Drug Clinical Trial Management Measures (CTR) and Appendix VI on the IMP labeling workflow, which aims to improve the safety and efficiency of clinical trials, is also a hot topic in the regulatory field.

However, with the continuous change of regulatory requirements and the increasing amount of data, global regulatory teams are facing greater pressure. In order to meet these challenges, digitalization, process automation and centralized management have become key strategies to ensure that pharmaceutical companies can submit materials to regulatory agencies smoothly. As the amount and complexity of data increase, the digitalization and optimization process of the pharmaceutical industry will continue to deepen.

Key challenges facing global pharmaceutical regulatory teams

Although automation technology has been widely used, global pharmaceutical regulatory submission teams still face many challenges, especially in managing and applying new technologies. A key issue is the lack of unified standards and coordination among global regulatory agencies, such as the differences between the China National Medical Products Administration (NMPA), the US FDA, and the European Medicines Agency (EMA). How to keep up with these different requirements remains a challenge.

In addition, decentralized management has also caused many difficulties for pharmaceutical companies, which not only affects quality control and on-time project delivery, but also leads to a lack of transparency in project costs and performance evaluation. The inability to achieve scale management between regions, business departments and therapeutic areas has made pharmaceutical companies face severe challenges in promoting regulatory coordination.

According to research forecasts, by 2025, global regulatory agencies will achieve more efficient coordination to shorten submission time and reduce safety risks. Therefore, using technology frameworks to achieve centralized management and keep up with the rapid changes in the industry will be a priority for pharmaceutical companies.

Three benefits of centralized global regulatory content management

1. processed , the pressure on the team is particularly great, and any inconsistency in quality will threaten the timeliness of submission and may even cause the deadline to be missed.

Using AI-driven workflows to process regulatory materials can not only reduce project management time and costs, but also shorten submission times and flexibly scale according to the amount of content required. At the same time, centralized solutions improve translation efficiency, reduce delays caused by errors, and better adapt to the translation needs of different markets by leveraging translation memory (TM), glossaries, and style guides.

2. Ensure consistency and scalability Decentralized regulatory workflows can lead to inconsistent submission quality and lack of visibility into project costs and performance. Especially when local teams manage translation projects and are overseen by global teams, quality and transparency issues often arise. With increased risk and the possibility of fines, inconsistencies across multiple processes can result in significant financial losses for pharmaceutical companies.

By combining artificial intelligence technology to centrally manage global regulatory content, regulatory teams can handle content at a larger scale without sacrificing quality and consistency. This process is enabled by more efficient editorial workflows, strict version control, and built-in content evaluation capabilities. Built-in reporting capabilities help teams monitor project progress in real time and quickly resolve potential issues to reduce compliance and quality risks. After implementing this strategy, teams can expect to reduce project management time by up to 53% and translation cycle times by up to 70% within six months.

3. Improve ROI By centralizing the management of operating costs across multiple sites, pharmaceutical companies can significantly increase ROI. With a one-time fee to build a centralized platform, you can increase project management efficiency and reduce full-time employee (FTE)-related costs, such as training fees and project management hours, by integrating artificial intelligence and automation into your workflow. Can be easily tracked and reported.

Furthermore, eliminating data silos and improving the efficiency of data monitoring and reporting can effectively reduce financial risks. Through refined regulatory workflows and consistency across global sites, errors and delays are reduced, further improving ROI and shortening the time to market for products. Overall, implementing a strong centralized strategy is expected to save millions in costs in the submission process.

In summary, digital transformation and centralized management are becoming key competitive advantages in the pharmaceutical industry. With the help of advanced technology platforms, pharmaceutical companies can improve work efficiency, shorten project cycles, and maximize their return on investment. Through effective centralized regulatory content management, pharmaceutical companies can remain competitive in a complex and changing global regulatory environment and ensure the smooth completion of projects.

◀️：Five Ways to Improve Your Translation Project Selection Process

▶️：Gaming Industry Trends in 2024