AI is among the hottest topics, affecting every corner of nearly every industry. It continues to become deeply ingrained in everyday operations, and there is a strong case that 2025 will see a continuation of this, especially within lifecycle maintenance (LCM) and regulatory affairs.

Traditionally, the approach to compliance has been reactionary, but with AI, the approach will become more proactive. This new approach will be one that anticipates regulatory shifts, optimizes the decision-making process, enhances global agility and redefines resource allocation. With AI at the forefront, organizations stand to achieve compliance while also tapping into efficiencies that will provide a new level of competitiveness in a complex regulatory environment.

Regulatory Compliance

One of the most significant challenges within regulatory lifecycle management is navigating the ever-changing laws, policies and regulations that govern pharma. This challenge is further intensified when organizations are required to manage variations across multiple markets, which is crucial for maintaining their licenses. To ensure compliance, organizations will turn to AI as a resource for automated tracking and interpreting regulatory updates globally, providing real-time insights.

 Another area of lifecycle management that stands to benefit from the adoption of AI is regulatory submission preparation. Traditionally, writing regulatory documents has been both time-consuming and resource intensive. However, with a modern AI-enhanced approach, this process, including file preparation, can be automated and streamlined. By leveraging efficient automation, regulatory filings can be generated faster and, most importantly, with greater accuracy.

The effects of automated file authoring don’t just end with the generation of new documentation. Another realized benefit is the burden lifted from the shoulders of those who were tasked with status tracking, reviews and approvals. Eliminating this burden opens the door to reprioritizing higher-value tasks and activities. 

License Management

A key AI trend to monitor is its ability to play a pivotal role in managing regulatory licenses. This will allow organizations to quickly assess the status of current licenses and understand how potential regulatory changes will impact them. Leveraging AI, licenses that could potentially be placed at risk or require essential updates can be identified and assessed prior to any effects being felt. This proactive approach is one that ensures continuous compliance. 

With a comprehensive view of the status of licenses and additional insights into the impacts of regulatory changes set to take place, organizations can ensure that they are remaining compliant, thereby preventing any potential delays that could lead to significant financial and reputational damage. This capability to proactively manage licenses will minimize compliance risks and increase the competition among companies in a fast-evolving regulatory landscape.

AI’s Impact on CMC

Another area of impact from the adoption of AI will be in chemistry, manufacturing, and controls (CMC) variations, a critical component of maintaining or improving product quality. CMC variations can be complex, potentially requiring extensive assessments and detailed document submissions that vary by country. This is where AI will become a pivotal tool by streamlining the CMC change assessment and allowing companies to make the right decisions about when and where to proceed with certain variations implementation. 

However, CMC-related tasks will be dependent on one crucial factor, which is whether companies are able to adhere to good manufacturing and documentation practices. If this condition is met, AI will reduce the time regulatory professionals spend on CMC-related tasks. Once again, using automation lifts the time-consuming burden of compiling regulatory requirements and preparing files from the staff so they may focus on other tasks, such as implementing necessary changes faster and more efficiently. This efficiency will lower operational costs and reduce the time required to complete CMC variation procedures. This additional time gives companies an advantage in managing their regulatory requirements.

Marcela Miño is the global head of the marketed pharmaceutical products’ lifecycle maintenance business at IQVIA. As the global lead of a high-performance regulatory team, she supports activities worldwide. Located in Argentina, she holds an MBA and has over 18 years of regulatory experience with IQVIA and 10 years of prior experience in the pharmaceutical industry.