Design a Streamlined Regulatory Workflow with AI

As pharmaceutical regulation continues to diversify for global and local markets and adapts to accommodate increasingly complex pharmaceuticals, many sponsors are renegotiating how they conduct their regulatory workflows. New technologies are emerging to help augment the workloads of overburdened regulatory workers, including artificial intelligence (AI), machine learning (ML), robotic process automation (RPA), natural language processing (NLP), ChatGPT, and more. By leveraging these technologies, sponsors are better positioned to meet their regulatory management goals, which include:

• Optimal and timely compliance with regulations across the full product lifecycle
• Expanded and accelerated patient access via optimized regulatory pathways and operations
• Shortened timelines to approval thanks to efficient systems

A Look Inside the Augmented Regulatory Worker Model

Systemic regulatory augmentation does not aim to make human regulatory workers obsolete, but rather, to assist them in leveraging their expertise and reducing their busy work. By using innovative technology and high-quality data to implement automations, regulatory workers can increase their productivity and focus their efforts in a more targeted fashion. The augmentation breaks down into three tiers:

• Full automation/low complexity: low complexity activities like bots and rule-based automations, including RPA, AI, or automations built into applications
• Semi automation/mid-range complexity: data extraction, data transformation between formats, suggestions based on experience, and content generation via AI, ML, NLP, and LLM
• Exploration/high complexity: using the same technologies in more exploratory ways for strategy and planning, including smart searches, summarization, data analysis, or information provided via chatbots

To establish streamlined automation systems, companies will need to rely on data governance, integrated regulatory information management (RIM) platforms, and regulatory intelligence. For sponsors struggling to navigate regulatory management with their current resources, opting to partner with an experienced regulatory resources organization can help your team mitigate high costs, navigate unplanned regulatory events, and work smarter rather than harder. Furthermore, an outsourcing partner can help your team implement new technologies to ensure better service and high efficiency processes.

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