Pharmaceutical regulators are facing ever-evolving, complex, and stringent requirements for the regulatory approval of new and existing products on the market. What’s more, as technology changes our ability to capture data from more sources, the volume of data in the life sciences sphere is growing exponentially, creating a challenging data analytics paradigm. The key is how to best leverage this data consistently along with automation technology to drive greater efficiencies in the regulatory process and enable the regulatory teams to focus on higher-level strategic projects. 

The Changing Landscape in Pharma

Forty years ago, documentation that needed to be submitted for an original drug product approval averaged about 50 pages, while today it’s typically thousands. The increase of required information within submissions ensures patients have safer and more effective treatments coming to market, but creating the documentation is a time-consuming challenge that can’t be solved by just hiring more staff. Rather, outsourcing and automatic data analysis is a critical step for every company. 

Simultaneously, there is an evolution taking place around who and what needs to be included in the lifecycle of regulatory submissions. As more and more processes are being digitalized, the fact that people are working in silos has become more of a hindrance than ever. While significant progress has been made in the last two to three years to integrate regulatory information across organizations, more is still needed, especially as it is critical to ensure data consistency across all submissions.

Legacy processes for regulatory strategy, tracking, and publishing are hard to break from; yet it is exactly what is needed as pharmaceutical companies undergo digital transformation. Internal teams must embrace how data can be leveraged and shared across the organization. Furthermore, sharing and reuse of data can be extended to external partners. By doing so, they create better data consistency and streamlining of the regulatory process. In fact, firms in Europe that have accepted and implemented automated data technologies for electronic processing and publishing methods are seeing a number of benefits as a result. 

The Benefits of Automated Regulatory Submissions

With the proper tools and implementation efforts, the transition to electronic publishing of regulatory submissions represents the first step toward sufficiently supporting advanced compliance in the modern regulatory landscape. As both unstructured and structured healthcare data grow, technologies such as AI/ML and natural language processing (NLP) assist in automating how it is used in regulatory information management frameworks. The programmed use and reuse of approved data and content assists in bringing products to market faster – an overall goal of every company.  

This digital approach introduces a strategic, holistic method to how data is used across the organization for regulatory purposes. Automated regulatory information management frameworks make data much more readily usable, consistent with the correct context. Intelligent templates pull information from integrated data sources to assemble the regulatory document, a breakthrough process in the life sciences industry. Integrated cross-functional systems can automate notification of submission requirements across the entire organization so the process can begin sooner. The greater consistency of information and fewer errors with data-driven submissions is a vast improvement upon the manual document creation process of old. 

Finally, as life sciences companies work to keep pace with changing regulations, the biggest constraints they face are time and the ever-increasing scope of data. Every day that a regulatory review process can be shortened, companies can be competitive on introducing new solutions that could result in millions of dollars in revenue. It also allows for the regulatory teams to better use and analyze data faster, build closer relationships with local and country regulators, and develop brand recognition.

Change Management Considerations 

As with any kind of digital transformation, new technology is nothing without a plan to intuitively embed different processes into the organization to ensure user adoption. To achieve this, an organization’s partners can best assist by bridging the gaps to accomplishing these goals without taking the company’s focus off regulatory adherence in the interim. When evaluating the short- and long-term cost versus benefit of a technology service partner, critical considerations for successful change management include:

• The past and future of their technology roadmap, including milestone metrics
• Their willingness to work with other systems to achieve the organizations goals
• Their ability to continuously adapt the technology to new regulatory demands 
• The additional services they offer to support your implementation and user adoption

Strategic change management is essential to a smooth transition during these changes. Employees will need to be trained for new skillsets in an electronic environment. Learning to manage document versions, tracking through smart technology, optimizing and consolidating the tracking of changing regulations, and understanding content management systems will be essential to maintaining an effective regulatory information approach. In turn, employees will need available time to dedicate to learning new systems. This is a key opportunity to leverage regulatory outsourcing. Even on a temporary basis, a solid technology partner who can also provide outsourcing services can substantially reduce ramp-up time on new technologies and even help the organization develop new processes based on best practices.

Digital transformation like that of regulatory publishing processes proves to be increasingly essential to stay ahead of the curve in the life sciences market. These companies must embrace how data and automation technologies will change operations and speed electronic publishing submissions and regulatory information management. While it won’t be an easy feat to truly change legacy processes, the benefits outweigh the challenges. When organizations take the time to plan their implementation strategy, automated electronic publishing will deliver its full promise of faster submission review times, higher transparency, and better data quality. In this way, life sciences organizations can transform their regulatory divisions into efficient drivers of value while providing a competitive advantage.