Do We Really Need Regulatory Intelligence?
Regulatory intelligence (RI) has emerged as an essential tool for regulatory professionals, but do we really need it? The simple answer is, yes. Using RI will help you to become an effective regulatory professional by helping you to develop the most effective regulatory strategies, while at the same time helping to avoid costly and time-consuming mistakes that can leave you vulnerable to legal ramifications. Chances are, you’re already using RI to some degree, but you may want to consider using it more.
Unlike what you may think, RI doesn’t take a lot of expertise. When you’re looking up product approvals or guidance documents to evaluate the regulatory environment, or when you track a competitor’s recall to learn from their mistakes – you’re using RI. However, according to an article published by Sharon DeGrove Bishop, RAC, “true” RI involves gathering the most comprehensive information available, analyzing it, and determining the most effective strategy to address a particular need in the regulatory environment. In order to have effective RI, you need to acquire the necessary tools and develop methods that will help you reduce the amount of time you spend researching and organizing information, which will allow you to spend more time developing analyses, insights, and strategies.
Let’s dive in to discussing why RI is essential for your professional career…
Change – Lots of Change!
Things are constantly changing in the regulatory profession and if you don’t keep up, you’re at an increased risk of liability, according to Diane Fleetwood. To start, let’s talk about guidance guidelines – 243 new guidance documents were issued in 2015, compared to just 117 in 2012. These new changes, however small they may be, have a significant impact on the regulatory environment. Couple these changes with the US Department of Justice taking action on individual employee liability and things can get complication. You’ll start to see executives facing criminal penalties for corporate mistakes, despite the fact that they may not have been personally aware of the particular noncompliant issue. In summary – keeping up with regulatory changes is not only good for your company; it’s essential for your personal protection.
Data for Decisions
Effective and efficient decisions are dependent on the quality and effectiveness of your data analysis and interpretation. It has been found that companies that make decisions that are data-driven have 4% higher rates of productivity and 6% higher profits than other organizations. The numbers don’t lie – these percentages equal a higher profit so they shouldn’t be ignored.
Benefits of RI – it’s not just the bottom line!
Let’s keep going with numbers here and talk about return on investment (or hard benefits) of RI implementation. While this is a critical question, the answer isn’t an easy one. Diane Fleetwood gets into great detail about “hard” and “soft” benefits of RI and we’ll try to break it down for you here.
The most obvious ROI calculation is the time and money saved by minimizing or eliminating manual processes and replacing them with automated ones. An example of how this works is by having an integrated RI system that eliminates the need to manually update spreadsheets. Additionally, an RI system that organizes all relevant documents, accurately, into one search, will help to improve data-driven regulatory decisions.
So, how does this equate to ROI – well, from a revenue growth perspective, if your company’s new product is expected to generate $10 million in incremental sales, there is an obvious value to your company if the regulatory professional can get it approved sooner by using more advanced RI and research, isn’t there? From a cost reduction perspective, if your regulatory professional is able to justify fewer clinical studies by using advanced RI, doesn’t this lead to improved regulatory results and cost savings to the company? While we may not be able to clearly put a value on the ROI, there is a definite value and benefit to using RI.
While you may want more “hard” benefits to support the use of RI, you have to remember there are also less tangible, and harder to measure benefits (“soft” benefits) of RI implementation. When discussing soft benefits, you need to keep cost avoidance strategies in mind. A great example of this is an integrated RI system that automates the manual submission process, which can formalize and improve the accuracy of each submission. This may allow your company to increase the number of new products while increasing productivity and standardizing the processes. Additionally, an effective RI system quickly and easily monitors how the US Food and Drug Administration may be shifting their requirements in particular categories over time. Is there value for your company in being able to adequately anticipate shifts in FDA requirements for your next submission? Of course there is. It may not be a measurable value, but there is definitely a value. Another advantage of a good RI system is the ability to comprehensively track competitor’s activity, without requiring an excessive amount of man-hours to accomplish this task. Is there a value in making strategic decisions based on your competitor’s actions? Again, of course there is. Yet, another “soft” benefit of a good RI system is gaining insight into the site inspection and warning letter trends of particular FDA offices prior to your next inspection, which helps save time and puts you a step ahead of your competition.
When discussing soft benefits, the list goes on and on, and you need to stay focused on these benefits. Simply trying to calculate ROI does not always work – the main intangible benefit of RI is strategic value and this is hard to quantify.
Big or Small, You Need RI
Whether your company is large or small, you should be utilizing RI. Yes, larger companies have the advantage of having more staff to evaluate the regulatory environment, but there are a variety of tools emerging for smaller companies for document management, analytics and intelligence that can help to close the gap. These new tools are helping to improve time-consuming tasks such as document searches and management by automating them, thereby allowing regulatory professionals to spend their time on analysis, insight and strategic planning. These new programs are making RI more accessible to smaller companies that can’t necessarily devote the required hours necessary for manual approaches.
You may be thinking you don’t have time to implement RI, but by perfecting your RI strategies you will be able to work more effectively and efficiently in an ever-changing environment.