Business Problem

• Critical Regulatory Compliance: The client faced critical setbacks due to delays in updating product labels, resulting in substantial regulatory fines and enforcement actions. These lapses not only led to financial penalties but also damaged the credibility with regulatory agencies. The inability to keep pace with evolving global regulations underscored the urgent need for a reliable, automated system to ensure timely and accurate label updates, safeguarding both compliance and brand reputation.

• Time-Consuming Research: They were spending up to 60% of their time on manual research across clinical, regulatory, safety, labeling, and medical domains. According to an industry report, pharmaceutical companies lose an average of $1.2 million annually per product due to delays in decision-making caused by fragmented data and siloed workflows. They spent countless hours gathering and verifying information, delaying key decisions, and reducing operational agility.

• Inefficient Safety Surveillance: Traditional, manual methods of analyzing adverse events were not only time-intensive but also prone to human error. These inefficiencies delayed regulatory submissions, compromised patient safety, and limited the client’s ability to proactively identify and mitigate safety signals. The lack of real-time surveillance tools diminished operational effectiveness and posed significant risks in ensuring ongoing product safety and compliance.

Solution Approach

• Automated Label Comparison for Streamlined Regulatory Workflows: To overcome the challenges of manual label reviews, we implemented a powerful automation solution that simplifies regulatory workflows. This system creates side-by-side comparisons of competitive and historical drug labels, clearly highlighting changes across key sections such as indications, warnings, and dosage instructions. By eliminating the need for tedious manual work, the client has improved accuracy, reduced the risk of oversight, and accelerated the process of label updates across global markets, ensuring continuous regulatory alignment and smoother submissions.

• Developed AI-Powered Safety Surveillance for Proactive Risk Management: Introduced an AI-enabled safety surveillance system to modernize and enhance pharmacovigilance. It enables efficient comparison of adverse events across similar or companion drugs, quickly identifying patterns or emerging concerns. By automating the detection and analysis process, regulatory and safety teams can make more informed decisions, respond swiftly to potential risks, and maintain high standards of patient safety and compliance, shifting the organization from a reactive to a proactive risk management model.

• Optimized Regulatory Affairs Processes: Reimagined their regulatory affairs operations by integrating automation across core processes such as label harmonization, competitive analysis, and precedent research. This transformation reduced administrative workload, improved collaboration between cross-functional teams, and enabled faster, more strategic decision-making.

• Comprehensive Data Integration: The platform was designed to aggregate a vast and diverse range of scientific and regulatory data into a single, accessible system. This includes 67 million scientific literature citations, 1 million clinical trials, 500,000 product labels from 9 major health authorities, 120,000 approval packages from the FDA and EMA, 47,000 FDA guidance documents, 24 million patents, and insights from 300,000 global medical congresses. This comprehensive integration ensures that the client has real-time access to critical information for regulatory compliance, safety surveillance, and strategic decision-making.