The regulatory landscape is continually evolving, prompting pharmaceutical companies to adjust their strategies to remain in compliance with existing requirements. Since the remote shift throughout the COVID-19 pandemic, regulatory teams have been gradually embracing digitization in their workflows. While this has brought a host of unfamiliar complexities and challenges, it has enabled teams to reduce submission times, work more collaboratively, and increase visibility into all stages of the regulatory process. For example, a major topic of conversation in the regulatory field focuses on the EU CTR and the impact of Annex VI on IMP labeling workflows, which ultimately aims to improve clinical trial safety and efficiency.
Teams are under increasing pressure to process larger volumes of regulatory materials in shorter timeframes. To help with this, digitization, process automation, and centralization have been instrumental in ensuring pharmaceutical companies’ successful submission to regulatory authorities. As datasets continue to grow and become more complex to manage, we are likely to see further digitization and optimization within the industry.
Global Challenges for Regulatory Teams
Despite the incorporation of automated technologies, global regulatory submissions teams continue to face a plethora of challenges with managing and leveraging new technologies. One of the major concerns surrounds the lack of alignment across various global regulatory authorities, such as the FDA, EMA, and Health Canada, and keeping pace with the wide range of individual requirements.
Decentralization is also a major issue for pharma organizations, causing knock-on effects for quality, meeting project deadlines, and visibility into project spend and performance. An inability to scale across geographies, business units, and therapeutic areas places pharma companies in a precarious position in the move toward increased regulatory harmonization, raising questions about how efficiently resources are being used.
Based on ongoing efforts to harmonize global regulators, research predicts that by 2025, regulatory authorities will become coordinated at national and international levels to reduce the time to submissions and mitigate security risks. In the meantime, leveraging technology frameworks to centralize and manage multiple submissions and remain in lockstep with this evolving landscape should be a top priority.
3 Benefits of Centralizing Global Content Solutions for Regulatory Teams
1. Decreased Submission Timelines
A key concern for global regulatory teams is adhering to project timelines to be able to meet stringent deadlines and maximize time-to-market. Inconsistencies in quality across different teams may threaten timelines and result in missed deadlines, particularly where teams are under pressure to process large volumes of documents.
Leveraging AI-powered workflows to process regulatory materials can reduce project management time, lower costs, and shorten timelines, and it can also scale according to the amount of content required for regulatory approvals. Translating submissions into several languages is also streamlined, as a central solution enables teams to leverage translation memories (TMs), glossaries, and style guides to increase translation efficiencies and mitigate delays due to errors while accounting for differing requirements across markets.
2. Ensure Consistency and Scalability
Decentralization in regulatory workflows can cause issues with submission quality, such as a lack of insight into project costs and performance metrics. Local teams managing individual translation projects with oversight from global partners often bring challenges relating to quality and visibility. With increased risks and hefty penalties, inconsistency across multiple processes can cost pharmaceutical companies millions.
Centralizing your global regulatory content in tandem with AI allows regulatory teams to scale to process larger quantities of content without sacrificing quality or consistency across submission components. This is facilitated through more efficient editing workflows, tight version control, and content evaluation being baked into the overall workflow. Built-in reporting capabilities enable teams to monitor project progress and promptly address concerns, further curbing compliance and quality risks. Within six months of implementing this strategy, teams can expect to see up to a 53% reduction in project management time and up to a 70% reduction in translation cycle times.
3. Maximize ROI
Eliminating the costs associated with managing multiple sites through centralization enables pharma companies to maximize their ROI. Investing in a one-time setup fee for getting established on a central platform rapidly turns out more efficient project management workflows, and incorporating AI and automation into the mix reduces FTE-related costs, such as training and project management hours—all of which are easily trackable and reportable.
Furthermore, eliminating data silos and creating more efficiencies in data monitoring and reporting mitigates associated financial risks. With more fine-tuned regulatory workflows and consensus across global sites, there are fewer errors and delays, which allows for increased ROI and improved time-to-market. Overall, implementing a robust centralization strategy could yield millions in cost savings across the submissions process.
If you’d like to learn more about our central technology platform for global regulatory submissions, contact us today!