Regulatory submission and filing requirements have become more complex than ever before, and they’re not slowing down as technology opens doors to new methods and greater volumes of data for regulators to consider. In fact, we’re seeing regulatory agencies require much more information. Forty years ago, documentation that needed to be submitted may have averaged 50 pages, while today it could be thousands. Zooming in even further, the regional regulatory requirements that life sciences companies are subject to, depending on where they wish to market their products, become vaster and more difficult to manage the more global the company’s scale. 
 
It’s not an issue that can be solved with more new hires alone – particularly not in the midst of the multi-year talent shortage crisis that the industry currently faces. Rather, automation technologies can assist with these filing and publishing processes, allowing teams to focus on more strategic initiatives. But when the adoption of this information is forced, can it truly be embraced across the industry? Digital regulatory information frameworks must be adopted to optimize the submission process and ensure consistency of information. Technologies and data use only enhance regulatory filings as greater amounts of data and more complex information can be easily assessed. 
 
Gearing Up for Change
As life sciences companies pursue digitally transformed regulatory publishing and information practices, the biggest constraints they face is time and the volume of data to process. Time is money, and every day that they can shorten a review process could equate to millions in revenue, improved relationships with the local regulators, and invaluable brand recognition by patients and providers. Technology service partners can and should help bridge the gaps to advance digital transformation without taking the company’s focus off regulatory adherence. When evaluating the short- and long-term value of a partner to support the transition to digital processes, there are critical questions that companies should be asking, such as:

• Has the firm developed a roadmap at least 2 years into the future? Be sure to question their commitment to the technology and find out if they have met past roadmap milestones?
• Are they willing to work with other systems to help achieve your goals?
• How are they keeping their technology up-to-date with changing regulations? 
• Do they offer a healthy list of additional services to support your implementation?

From there, strategic change management is essential to a smooth transition. Employees will need to be trained for new skillsets in an electronic environment. Learning to manage document versions, keeping track of changing regulations, and understanding content management systems will be essential to maintain an effective publishing approach. 
 
There is also an evolution taking place around the lifecycle of a regulatory information publication itself and who and what needs to be included. As more and more processes are being digitalized, the fact that people are working in silos has become more of a hinderance than ever in the last several years. By integrating data use across the organization, it will ensure regulatory information become an efficient, cross-functional solution. 
 
We’re seeing more and more people in higher cost locations focusing more on long-term pre-planning and strategy behind their regulatory submissions. They are embracing technology solutions for their own regulatory maintenance, and regulatory operations and affairs teams are being streamlined in higher cost areas to justify the expenses around regulatory. By moving to electronic processes, companies can better observe their regulatory processes over time to determine the value of regulatory for understanding the efficacy of new products. Leaders can measure more closely the success of their planned submissions and return on investment. 
 
Realizing the Benefits
A transition to automated regulatory information management supports an enhanced compliance process that can handle the constantly changing regulatory requirements. As more and more structured data is generated and is tracked around these submissions, up and downstream visibility around submissions will improve. 
 
The digital approach allows companies to organize and take a more data-driven strategy when compiling submissions. Through automation, the data is much more readily usable. The ability to use data in context in documents, in which an intelligent template assembles the document for you, will enable better consistency of information. Finally, digitization will allow for quicker review of information, higher transparency, higher data quality to justify the cost of regulatory activities driven by regulatory requirements. As an industry, these capabilities unlock the increasingly critical capability to maintain compliance more easily as regulations change and retain a competitive edge in delivering effective and innovative new medical products to the market.

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