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Regulatory Information Management: A Fresh Look

Updated: Jul 5, 2021

According to the 2019 Global Life Sciences Outlook by Deloitte, global health care spending is projected to reach $10.059 trillion by 2022. The industry is expanding rapidly, with more and more small niche companies battling the large pharma companies in the cutthroat race to be first over the finish line, and get products to market. Proper documentation is absolutely crucial in this process, it needs to be kept in check throughout and easily accessible to all the necessary parties. Previously, multiple silo systems were required, each responsible for documenting a different part of the process; this, however, only complicates the task. Some documents end up with incorrect tags, time is wasted on locating the latest version of paperwork or even, on recreating existing files due to improper organisation. This can be detrimental to a company’s progress and can cause significant financial losses when each day late to file a submission can cost $2m+ lost revenue for a $1bn blockbuster drug.

These days, organisations need to be able to react to multiple country agency requests and filings in parallel, pre-emptively prevent issues with new documents through leveraging regulatory intelligence from one submission to the next to get an advantage on competitors. A reliable submission planning process using this intelligence provides a measurable benefit to companies, driving investment in enhanced RIM capabilities. A stand-alone RIM system will not, however, ever provide the full advantages of one that is integrated in both your submission content and IDMP information. A more holistic and dynamic approach to RIM is needed, the Generis system CARA for example, provides strong end to end RIM capabilities for both established and developing pharma enterprises. Information which is locked inside static documents or single-use databases cannot be used to its full potential.

So, what exactly are the requirements? A single user interface for RIM simplifies the business user’s experience, a solution which can either replace or connect to existing systems and reduce the need for data migrations. A dynamic RIM software is more efficient: it permits smarter ways of working with simple lifecycle and workflow management. Many products require multiple contributors and therefore, structured content authoring needs to be streamlined and easily accessible for all the players within the assembly of routine documents. Lastly, product and regulatory information has to be more shareable between specific functions in business, and even beyond.

CARA provides the optimum solution to these requirements. It allows users to access and manage information through a single user interface as well as letting them use existing systems as much as possible, to avoid data migrations and a single point of failure. It sits on a range of content management repositories and has been integrated with multiple CTMS systems and labelling management databases – all with 21 CFR Part 11 compliance.

We must look at RIM within the wider community of pharma companies, vendors and consultants.  It is imperative that data management and regulatory solutions permit the easy flow of information between different parts of the whole industry to enable effective co-working with a focus on end user experience.

Coming back to that opening question – CARA can provide you the means to see in seconds what you have registered where, and what upcoming tasks there are to keep your products successfully on the market.

A major aspect of successful business processes is maintaining a consistent dialogue with affiliates and distributors globally – this will be explored in our upcoming webinar: “Efficient RIM – Get Your Affiliates on Board”. In addition, we will explore how CARA can effectively fulfil all your RIM requirements.

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