Regulatory Intelligence is at the heart of every well-informed regulatory decision. True Regulatory Intelligence is gathering the most complete information available, analyses it to develop in-depth insights, and determines the most effective strategy to address a need in the regulated environment.
You may be doing this every day to some extent already. The key is to elevate your process to the highest level of proficiency which can save tremendous amounts of valuable time and allow you to make better informed decisions.
To give just a few examples:
- Finding the right document that provides you with a superior predicate device can bring a huge return in the form of a shorter or lower-cost pathway to clearance.
- Being able to provide an analysis of adverse events to your R&D group might result in a better product design that can yield greater product sales and fewer adverse events.
- The ability to quickly analyse how Health Authorities are shifting in their submission requirements can save months of extra work.
Good regulatory intelligence - using the right tools - more than pays for itself.
Effective regulatory intelligence cannot be performed at a high level with yesterday’s methods. To be effective, you need to have the ability to quickly see the big picture and connect the dots between pieces of information housed in disparate documents or data sets. You have to find efficient ways to capture and analyse trends. You need quick, reliable methods to monitor the increasingly dynamic environment. And you must develop the analytics that will provide you insights resulting in superior strategies.
Source: RAPS (Regulatory Affairs Professionals Society)