Regulatory Affairs Analytics

Behind every regulatory operations workflow, registration submission, health authority interaction, there lies data ripe for analysis. This data is probably one of the most important resources a life science organisation can possess. Utilising analysis of this regulatory data can help drive change with positive outcomes to support increases in efficiency and revenue generation. There is a wealth of information available to your organisation if you are ready to embrace it.

It is vital for every regulatory strategic plan and decision to be grounded in solid data. Data analytics can provide you with key insights that help you make the best choices in the ever-evolving regulatory environment. Analysis of this data supports the regulatory team in:

  • the development of a clear idea of the right road to achieving targeted business goals
  • what is happening in real time with regulatory submissions
  • establishing the next steps to remain competitive

Set Realistic Goals

Setting goals for your regulatory submissions sometimes involves educated guesswork without the right information. Submission goals should not be a moving target. Using analytics, you will be able to assemble data from historic trends and previous regulatory interactions, enabling the team to have a clear idea of what the goals should and can be, right from the project initiation. This ensures that you do not miss opportunities to obtain faster approvals and thus achieving a revenue generating marketing status. Review of the analytics supports a transparent understanding of when achievement of certain described goals are not possible. Analysis may also show the weaknesses of your processes so that you can initiate timely improvement. 


Regulatory affairs intuition and experience are invaluable, but some decisions that affect key business objectives ought to rely on actual data. Regulatory strategy and determination of possible registration outcomes rely on this background data.  Even when it comes to resource management, actionable data can help determine how best to deploy limited resources. Organisations utilising regulatory analytics are more likely to improve their decision-making process for optimal success.

Senior management relies on the regulatory function to provide guidance for cross-functional decision making, affecting the efficiencies across the organisation. Presenting the data in a visually captivating way, making the data more interesting (wow – interesting data!) and helps to address the need for faster, accurate reviews and an agile decision turnaround.

Curtailing Regulatory Risks

Making the right decisions based upon sound data should decrease the prospect for added risks. Avoidance of unacceptable regulatory risk may be achieved in the short and long term though data analysis. Regulatory teams should no longer make the wrong decision or subject a project to increased risk due to a lack of information or inaccurate information.  As we all know, failing to adequately determine regulatory risk may have catastrophic consequences in the form of field safety actions, market withdrawal or a reduction in health authority confidence.

Cost Effectiveness

Analytics can play a major role in decreasing the burden of regulatory costs. Measuring performance and effectiveness makes it easy to see which regulatory strategies worked and which presented sophisticated challenges. Saving time and resource in the pursuit of registration approval, key performance indicator for RA, becomes more manageable with the right data supporting decisions.

Regulatory Intelligence

Your regulatory processes capture data unique to your company, regions, teams, and product portfolios. No one outside the organisation has access to this information. The analysis output, when combined with publicly available information, can be leveraged to increase competitive advantages. A breakdown of the past helps to draw your plans for the future.

Data analytics is the cornerstone of regulatory information management software solutions. It is now easier than ever to obtain the pertinent data and reports that will support your regulatory business decision making objectives. Imagine a dashboard tool that creates easy to read and interpret visual representations of your valuable data.

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K Young