Regulatory intelligence and regulatory information management are two essential technologies for medtech companies. Why? Because regulatory affairs (RA) is challenging. The number of regulated markets around the world is growing. Medical devices and in vitro diagnostics are now subject to over 130 different regional regulatory regimes. And these regulations are hardly static. This year alone has seen over 30 different changes.
To be successful in this environment, RA teams need access to trusted, up-to-date regulatory information for all of the markets they operate in, and they need to effectively manage regulatory processes across them. By partnering with Clarivate, Rimsys will offer a single, integrated solution that addresses both of these needs.
While the teams responsible for regulatory intelligence and processes like market submissions, or post market surveillance aren’t always the same, the work that they do is tightly aligned. Consider two examples: First is a new market submission for a medical device. To begin, RA teams need to find and understand the market entrance requirements for a particular country—what are the requirements, what forms and information are required, how long does the process take, etc? This critical first step is entirely an intelligence function. Then they need to consolidate all of the relevant information, format and package it according to the country requirements, and make the submission. This example is an initiated process that requires regulatory intelligence input, but the linkage can flow in the other direction as well.
Now let’s look at a hypothetical product that’s already in-market, but impacted by a pending regulatory change. RA professionals need to monitor relevant regulations to stay on top of changes, and then execute processes to assess the impact on their products in the market, and potentially submit additional information to maintain compliance.
Almost everything that RA teams do has both intelligence and process components, so it’s surprising that teams are often functionally segregated. The supporting technology that they adopt often mirrors this segregation as well, creating silos that make it difficult to fully digitize and automate end-to-end regulatory activities.
Information is the lifeblood of regulatory affairs. It underpins nearly all activities, and represents most of the time that RA professionals spend. In fact, RA professionals can spend 50% or more of their time just looking for information. A lot of this searching is due to the fact that regulatory information is fragmented, incomplete, and hard to find. Government documents often lack context, and aren’t translated. Consulting companies publish superficial summaries in the hopes of capturing search volume and prospective clients. RA professionals must wade through all of this with repeated searches to find information with enough detail to be actionable, and from a source that’s trustworthy.
Regulatory intelligence solutions (like Clarivate Cortellis) can significantly reduce the “looking for information” burden for RA teams. It gives them direct access to quality information in the form of both helpful expert summaries, and contextual links to government documents. Information is often translated by regulatory experts, rather than machines, to provide the most clarity to teams who are looking to understand (and comply with) global regulations.
Regulatory intelligence makes it easy to find trustworthy information, but they don’t make that information actionable. There is important additional context found in product and registration data that can help RA teams understand which information is most relevant to them (i.e. does this regulation impact my product). Any action taken as a result of insight gained through the tool is at some level manual as there’s often no way to directly associate activities and tasks with regulatory information.
Rather than finding information, regulatory information management (RIM) platforms help RA teams centralize, organize and manage it. In addition to relevant regulations, RA teams need to collect and maintain product registration information, certifications, expiration dates, and performance and safety information. Typically, all of this represents a huge amount of manual work handled via complex, color-coded spreadsheets.
RIM platforms (like Rimsys) help centralize all of this information and organize it in a way that is useful for regulatory processes. RA teams can consolidate information for market submissions, easily identify where products are being sold, and create and edit essential principles tables though a single interface without having to constantly re-discover the underlying information. They also provide automated workflow management tools—allowing teams to manage regulatory projects, route and capture approvals, and maintain an activity audit trail.
The capabilities of a RIM platform are even more effective when they can be paired with regulatory intelligence. When linked at the product level, RA teams can easily identify market requirements for initial clearance, or understand the regulatory implications of product updates. If regulations change or new guidance is enacted, RA teams can immediately identify the impacted products (if any) and kick-off mitigation processes.
Today we announced a new partnership with Clarivate to bring together regulatory intelligence from Clarivate Cortellis with regulatory information management from the Rimsys Platform. This combined offering will allow RA professionals to access 200k+ trusted regulatory documents from over 80 countries, and harness that insight directly in automated workflows. With Rimsys Advanced Intelligence, global regulations can be associated with individual products to streamline market submissions, and quickly understand the impact of changes. RA teams can monitor specific regulations and receive alerts when things change. In the future they’ll be able to kick-off automated processes in response to regulatory change—bringing intelligence and execution into complete alignment.
Rimsys Advanced Intelligence provides:
Regulatory intelligence, and regulatory information management are essential for medtech companies that want to keep pace with the growing complexity of medical technology regulations around the world. However, both of these capabilities are dependent on each other, and far more effective when they’re used together. Rimsys Advanced Intelligence brings together the leading regulatory intelligence database with the leading regulatory information management platform for medtech companies. This result is greater productivity—RA teams spend much less time searching for information, and executing repetitive manual tasks, and greater compliance—Teams act on correct, up-to-date information, and have shared access to centralized registration, selling status, UDI, and essential principles data.