Regulatory Information Management (RIM) refers to an organization or team’s ability to manage and support global regulatory activities. Teams historically stored and managed regulatory information across a variety of systems, databases, and file shares spanning multiple geographic locations. This led to difficulties getting a holistic view of key regulatory activities, especially in a timely way.
As organizations have expanded their operations globally, it’s become increasingly more complex to keep up with submission cycles and health authority requirements across an entire product portfolio.
Regulatory teams are turning to software systems known as Regulatory Information Management Systems (RIMS) to help them ease the burden of manually managing regulatory activity. RIMS offer a centralized platform to track all stages of the product application and development lifecycle for pharmaceutical drugs, biologics, medical devices, and more.
This article will explore how RIMS aid in regulatory information management and how regulatory affairs teams can find the right RIMS system and vendor to support their global operations.
The Role of Regulatory Affairs in Regulatory Information Management
Regulatory affairs is a role within a life science organization tasked with overseeing and managing the process of bringing a new product to market, keeping current with regulatory oversight of products already on the market, and facilitating interactions with local health authorities.
As such, regulatory affairs teams perform a critical role across a product’s entire development lifecycle. Managing the regulatory information lifecycle from end-to-end comes with a host of responsibilities that can be grouped into three primary categories:
- Product lifecycle management—
- Regulatory affairs have a hand in pre-, active-, and post-market placement of a new product. Pre-market responsibilities span from collecting product registration information to managing the planning and tracking of all submission documents. Active products need support with market placement and standards management oversight. Post-market, the regulatory affairs team is expected to run continued surveillance management.
- Submissions management —
- Document and submissions management is a key pillar of regulatory affairs’ regulatory function. From enabling authoring to reviewing, approving, and preparing of submission documents for publishing – regulatory affairs oversee all aspects of regulatory content planning to ensure that all submissions are compliant and completed in the market-specific format.
- Throughout the entire lifecycle, regulatory affairs manage interactions with necessary health authorities and fulfill obligations in all desired target markets. This includes maintaining up-to-date tactical and operational filing requirements for local health authorities and working alongside R&D teams to conduct regulatory intelligence in target markets.
The role of regulatory affairs continues to evolve as new regulations or workflows are introduced. On January 31, 2023, regulatory affairs professionals overseeing applications for new investigational products in the EU will need to begin shifting their submissions from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Changes like these continue to introduce new workflows and add complexity to regulatory affairs’ workloads.
To help navigate the end-to-end regulatory information management lifecycle, many regulatory affairs leaders are turning to RIM System.
Why Should Regulatory Teams Consider a RIM System?
There are many reasons for life science organizations to consider a RIMS. Releasing new products to the market or maintaining an existing product can be complex and challenging to complete — especially while remaining compliant.
Regulations placed on pharmaceuticals, medical devices, and biologics are often lengthy, difficult to decipher, and can vary from country to country or even between regions. The differences between local health regulations pose a challenge for regulatory teams because the industry continues to trend towards global collaboration and operations.
Many regulatory affairs teams are also under growing demand for faster and more accurate data due to increased public and regulatory scrutiny. A large contributing factor to the new EU regulation scheduled for early next year is due to growing demand from the public and regulators for enhanced transparency and disclosure of clinical data. This demand for data speaks to society’s focus on evidence-based medicine, accelerating drug development timelines, and protecting patient safety through added transparency.
The challenge with meeting the demands for data transparency and global operations is that traditional workflows struggle to offer real-time, accurate overviews of global regulatory information. Rather than managing an entire product portfolio manually or through disparate systems, a centralized RIMS offers a regulatory affairs team a place to easily access all regulatory documents, supports electronic submissions, offer advanced preparation for the shift from CTD to CTR, and solves challenges along every stage of the drug development cycle with full visibility into the regulatory ecosystem.
Primary Functions of a Modern RIMS
How do RIMS empower regulatory teams? RIM software systems aid in four primary functions:
- Managing product dossiers
- Preparing and submitting product submissions in standardized and regulated formats
- Managing global communications and obligations to necessary regulatory bodies
- Managing an organization’s product portfolio in a centralized place by storing relevant details about their registration with various regulatory bodies
Streamlining these four functions into a single end-to-end RIMS allows organizations to gain 360° oversight of the regulatory lifecycle without having to waste time on manual efforts or delayed access to data.
How RIMS Streamlines Regulatory Information Management
RIM systems are helping regulatory teams unlock a multitude of benefits that aid in their regulatory information management efforts.
- The Power of 360 Visibility – RIMS offer centralized dashboards to monitor every task, submission deadline, and project status to equip teams with real-time data for strategic decision making.
- Connected Regulatory Teams – RIMS creates an opportunity to connect regulatory affairs with the larger regulatory ecosystem by aiding in seamless transitions of regulatory information between regulatory affairs, Regulatory Operations, HQ, and other key stakeholders.
- Automate to Accelerate – With flexible and standardized workflows, RIMS empower teams to move faster through dossiers and submission planning by offering automation capabilities that not only reduce human error, but also take burden off regulatory affairs through deadline setting, submission notifications, and role-based permissions.
- Simplified Regulatory Information Management – RIM solutions provide a means to simplify complexity with technology that scales alongside teams to stay on top of competing deadlines and requirements for multiple products across their entire lifecycle.
Ready to Get Started on Your RIMS Journey?
How do life science organizations know when it’s time to shift from manual or traditional RIM to a RIM system?
The first step is to understand your organization’s RIMS-readiness. Organizations who can benefit most from a RIM system are those looking to scale their existing product portfolio or expand operations globally. When regulatory teams begin surpassing their ability to manually manage submissions or keep up with health authority communications and/or fulfillments, that is a clear sign of RIMS-readiness. Additionally, regulatory teams that are looking to expand their product complexity, risk, or are planning for changes that may trigger re-registration activities, will find that a RIMS can help them with these changes.
As a first step in the process, organizations should begin by defining the metrics or goals they would like to achieve with regards to their regulatory information management. From there, teams can build a RIM roadmap to achieve those goals.