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The Future of Regulatory Automation: Breaking Down the AI and Regulatory Operations Landscape

Digitalization and automation tools in the biopharma regulatory operation space provide an opportunity to transform how pharmaceutical businesses collaborate to bring new, safe therapies to market.

This blog is part of our ongoing series, "The Future of Regulatory Automation in the Biopharma Industry."

The future of regulatory automation is the way forward for the industry. While pharmaceutical regulatory functions are already streamlining their automated processes, challenges remain in executing master data management plans and cultivating the necessary talent. Despite these hurdles, the market is ripe for automation, and new artificial intelligence (AI) and software tools are almost ready for prime time. With a machine-first mindset and a commitment to real-time evaluation of data, the path to a dynamic regulatory system is in place, bringing better outcomes to patients, payers and stakeholders faster.

AI and Regulatory Operations: Where Are We Now?

Regulatory automation is made possible by various technology tools, including AI-powered compliance management systems, which utilize algorithms and machine learning to identify and flag potential compliance risks. Other technologies used in regulatory automation include document storage solutions, submission publishing platforms and workflow management tools.

In addition to enhancing efficiency and simplifying operations, regulatory automation is essential for increasing the volume of work that pharmaceutical companies can handle while maintaining compliance and quality standards. For instance, authoring stability tables is a time-consuming and repetitive task requiring high accuracy. Utilizing a regulatory automation software tool can eliminate the need for manual data entry, enabling teams to focus on more critical tasks while enhancing accuracy and reducing the risk of errors.

Benefits of Regulatory Automation in the Life Sciences Industry

Regulatory automation helps to streamline their operations and reduce the risk of human error, ensuring that they remain compliant with the ever-evolving regulatory framework. The benefits of regulatory automation include:

  • Employee engagement: Regulatory automation helps by eliminating tedious tasks and offering opportunities to work with cutting-edge technology.
  • Increased efficiency: Automated processes and tools can help streamline operations, reducing the time and resources required to manage regulatory compliance.
  • Reduced compliance costs: Automated systems can help reduce the costs associated with regulatory compliance, such as the costs of manual data collection and analysis, by automating these processes.
  • Improved accuracy: Automated systems can help reduce the risk of human error, improving the accuracy of regulatory compliance data and reporting.
  • Enhanced risk management: Automated systems can help identify and address potential compliance issues before they become problems, reducing the risk of non-compliance and reputational damage.
  • Better data management: Automated systems can help ensure that regulatory data is accurate, up-to-date, and easily accessible, improving the quality of regulatory reporting.
  • Increased productivity: Automated systems can help clinical research partners and organizations (CROs) focus on more value-adding and strategic activities, increasing productivity and improving overall competitiveness.

If clinical research partners are selected to support regulatory activities and operations, it is critical that the strategy of the chosen partner is focused on providing optimum quality while increasingly demonstrating efficiency and productivity and providing cost efficiency back to clients. This alignment can help ensure regulatory automation tools are effectively utilized to achieve business objectives and meet compliance requirements.

Automation and Regulatory Operations: What’s on the Horizon?

Pharmaceutical regulation has always been an important topic due to the critical role of the industry in public health. To ensure that drugs are safe, effective and marketed appropriately, the regulatory framework in this sector is continuously evolving. The COVID-19 pandemic added new challenges, particularly the need for faster drug development, increasing the pressure on pharmaceutical companies to scale up their operations to meet demand. Meanwhile, organizations continue to face the challenge of keeping up to date with regulatory changes while dealing with resource limitations, such as budget constraints, limited availability of skilled personnel and physical space. To manage their operations more efficiently, many organizations are turning to automation solutions, which can reduce the risk of human error and ensure compliance with regulatory requirements.

A Note on Federal Compliance and Oversight

These revolutionary changes in regulatory operations will require meticulous and fast-moving oversight from federal agencies. The FDA's Knowledge-Based Authentication System for Authorized Access (KASA) and the EMA's tech initiatives demonstrate the growing importance of regulatory automation in the modern landscape. These technology solutions aim to streamline the regulatory compliance process and increase efficiency, accuracy and transparency. Including these technologies in the regulatory landscape highlights the growing recognition of the benefits of regulatory automation and the need for organizations to adopt these solutions to remain competitive and compliant.

In the future, regulatory authorities may require more real-time data monitoring and reporting, which would be difficult to achieve with manual processes alone. This could mean pharma companies could be forced to adopt automated solutions such as AI-powered compliance management systems to keep up with these new requirements. Without these automated solutions, companies may struggle to keep up with the volume and pace of data required for regulatory compliance, leading to delays, errors and potential non-compliance issues. In this way, manual processes alone may no longer be sufficient to meet the demands of regulatory authorities, and companies may be required to adopt automation to remain competitive and compliant.

Is your regulatory operations team looking for more insight into automation processes for regulatory processes? Contact the GRAS team to explore new options developed specifically by experts in regulatory operations for the life sciences industry.


Tapasya Bhardwaj
Associate Director, Regulatory Affairs | Consulting at Syneos Health
Keira Ledger
Senior Director, Regulatory Operations | Consulting at Syneos Health
Mark Bailey
Associate Director, Regulatory Affairs | Consulting at Syneos Health

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