Managing the submission of medicinal products, medical devices, and biologics to regulatory agencies is growing more complicated all the time. To streamline the processes that go into creating and tracking these submissions, life science organizations are increasingly relying on Regulatory Information Management Systems, or RIMS.
RIMS are software systems that aid in four primary functions: managing product dossiers, preparing and submitting product submissions in regulated formats, managing communications with and obligations to regulatory bodies, and managing the organization’s products by storing relevant details about their registration with various regulatory bodies. These systems are critical because of the complexity of the problems they solve. The regulations placed on medicinal products, medical devices, and biologics are complicated, lengthy, and vary from country to country or even region to region. Consider the cyclical nature of submissions, varying timelines for renewal, and new product candidates completing the Clinical phases at different paces — there are many moving parts to consider.
On the surface, all RIMS may seem the same, but how organizations approach compliance can set the leaders apart. A well-managed approach to Regulatory Affairs can shorten a product’s time to market, maximize revenues for the organization, and reduce indirect costs by increasing efficiency, product quality, and patient safety.
Choosing the best RIMS solution for your organization is key to realizing these benefits. Best-in-class solutions have a 360-degree approach to Regulatory Affairs and Operations, are equipped with the tools needed to uncover deep insights from data, and use automation to allow employees to work smarter, resulting in efficiency gains.
A 360-Degree Approach to the Submission Lifecycle
When it comes to managing submissions, there are two parts of the process: Regulatory Affairs and Regulatory Operations. The Regulatory Affairs team oversees strategic decision-making (such as which countries to seek approval in first) and submissions management (such as planning the various phases of submissions and approvals for a single drug or device candidate). Regulatory Operations, meanwhile, handles the tactical groundwork: the manual collection of data and preparation of submissions, which can be thousands of pages long. It’s important that these two teams work in tandem to keep submissions moving and ensure that products can be marketed and sold.
When thinking of the cyclical nature of regulatory submissions, it helps to picture a traffic circle. You can imagine how vehicles may enter and leave the circle from various places. Think of these vehicles as the medicinal product, medical device, or biologic that needs to be approved. Some may enter from the Clinical team, ready to go to their first round of clinical trials, or ready to be submitted for market approval for the very first time. Others may be coming from the market, in need of re-submission to approve product updates or revisions. Still others could be entering from a mid-point between the two, such as when an existing drug is submitted for approval of a new labeled use. Wherever the medicinal product, medical device, or biologic is in the circle at any given time represents where this product is in its lifecycle.
Traditionally, RIMS have been described as end-to-end, meaning they help Regulatory teams to oversee the approval of a given product from its inception to its post-market authorization and beyond; but this concept is short-sighted. It neglects to consider that there is no end point when it comes to the product lifecycle. That’s why today’s best RIMS solutions take a 360-degree approach to the submissions and product lifecycle, whether that begins at discovery, renewal, or label modification.
In practice, a 360-degree approach means providing insight to both the Regulatory Affairs and Regulatory Operations teams into one another’s efforts, allowing everyone to stay informed on the status of a given submission and product lifecycle. Most RIMS provide only the information aspect of the regulatory process, pulling completed dossiers and submissions and managing them on their way to the regulatory agency; but 360-degree RIMS allow the strategic function of Regulatory Affairs and the tactical function of Regulatory Operations to stay in lock-step with one another. Leveraging modern cloud technology, these new-age systems eliminate the need for multiple disconnected systems and provide total visibility into every stage of submission preparation, from data collection to dossier writing to the long-term, strategic management of medicinal products, medical devices, and biologics. Think of the RIMS as the GPS directing each individual vehicle: it holds the roadmap needed to keep data, submissions, and workflows moving appropriately and efficiently throughout the cyclical R&D process. These “vehicles” could hold anything from individual data points to content to dossiers.
By bringing both Regulatory Affairs and Operations under the same software umbrella, the organization can create a holistic view of the entire Regulatory function to create a more agile, organized, and efficient department. A single system comes with huge benefits, including:
- No data loss as documents are transferred between sites or systems. By keeping all data in one place, the Regulatory team can rely on the integrity of said data.
- No more lag time waiting for information to be shared, or for teams to pick up on a task from where their counterparts left off.
- Greater visibility into every aspect of submissions and easy assignment or reassignment of tasks to verified users.
- Reliable document management to eliminate duplicates and maintain an easy-to-follow document trail.
One of the many benefits of a single system for managing all Regulatory functions is the collecting of all data in a single place; but to really make the most of that data, you need the right tools to pull powerful insights from within. With these insights, your Regulatory Affairs team will be able to make decisions based on facts, not assumptions.
Top-tier RIMS solutions will be equipped with AI that will empower your organization to uncover insights from the data held by your Regulatory teams. If the RIMS solution also has an open architecture and can integrate with your other R&D solutions, this could be all research data held by the organization, presenting an enormous opportunity to leverage that data in decision-making. This could inform Regulatory Affairs teams as they decide when and where to prioritize submissions, how to work most efficiently, and how to maximize patient safety, ultimately leading to greater revenue and lower costs for the organization.
Powerful AI can also help these teams maintain compliance with a host of regional and country-specific standards, like IDMP or xEVMPD, by automatically checking submissions for compliance and helping teams to translate organization-specific referentials to those required by regulatory standards. Advanced data capabilities can even categorize data based on geography. Beyond compliance, teams are able to improve their operations and workflow with these critical tools independent of the standards. The IDMP standard, for example, has prompted many organizations to leverage technology that complements the workforce.
Automate to Accelerate
To optimize the operations of your Regulatory teams, seek a RIMS solution that is rich in automation capabilities. Not only do these significantly reduce the risk of human error, but they also take some of the burden off Regulatory Affairs teams by setting deadlines and using notifications to ensure submissions are completed in a timely fashion.
Automation within a RIMS solution could mean several benefits:
- Automatic deadline setting to ensure submissions are completed by the required date
- Automatic assigning of users, tasks, and deadlines that automatically populate triggers and reminders to ensure submissions stay on track
- Automatic triggers when Safety, Clinical, or Medical Affairs teams identify an adverse event so that the Regulatory team can identify the regulatory authorities in the required time frame
Simplify the Regulatory processes
RIMS solutions ultimately serve as a means of simplifying the Regulatory processes within life science organizations. Regulatory Affairs teams at scaling or large organizations must stay on top of many deadlines for various products at varying positions in their product lifecycle, meaning the Regulatory department never reached a true endpoint with any given product. For that reason, end-to-end solutions leave much to be desired; rather, RIMS solutions need to take a 360-degree approach to Regulatory Affairs.
When both the Regulatory Affairs and Regulatory Operations teams are able to work within the same software system, each team gets unparalleled visibility into the other’s workflows, helping all team members to stay on track and in lockstep with their counterparts. The result is more informed, effective, and efficient teams that can manage complex product lifecycles with ease
Learn more about the benefits of leveraging an interoperable RIMS across the entire R&D lifecycle.