To streamline processes and speed up overall regulatory submission timelines, life sciences organizations turn to regulatory information management systems. Unfortunately, these systems can also be fraught with mistakes and inefficiencies—threatening compliance. Here’s how to tell if you have a problem with yours.
Life sciences companies strive to improve people’s wellbeing by developing drugs, medical devices and more. However, to ensure these innovations are safe and effective, they must meet global regulatory agencies’ standards before heading to market—which is what regulatory information management (RIM) is designed to help with.
RIM is the process of managing and supporting global regulatory activities. This includes managing product information and submitting it to regulatory agencies for approval.
In the past, life sciences organizations used various manual systems to manage this information, ranging from Excel spreadsheets to pen and paper. However, regulations are becoming more and more complex and evolving at a rapid pace. To stay current with the changes—and maintain compliance, or risk facing hefty fines and penalties that jeopardize drug innovation—organizations have shifted to regulatory information management systems.
What Is a Regulatory Information Management System?
A RIM system streamlines global regulatory processes through data and content management solutions. It helps an organization remain compliant from the development through the marketed release of its new drug or medical device by:
- Preparing, managing and submitting product information to regulatory agencies in approved formats.
- Increasing transparency by tracking communication.
- Reducing manual errors.
Interfacing with the FDA, EMA and other regulatory bodies is a complex feat. Any errors in the submission process can lead to rejection, which can add months or years to the development time. Not only costing your organization but also preventing important drugs from getting to those who need them. RIM systems can help R&D teams interface more cleanly and efficiently with regulatory bodies—but only if their RIM system is up to snuff.
So, how do you know if your RIM system has a problem? Let’s look at four warning signs.
4 Signs Your Regulatory Information Management System Needs Optimization
1. Your Product Data and eCTD Solutions Are Not Integrated
If your RIM system doesn’t integrate Product data with your electronic Common Technical Document (eCTD) publishing solution, it can spell trouble for your submission timelines.
The eCTD is the standard format for submitting regulatory information to the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
When you submit an eCTD, it’s easier for regulatory agencies to review the data, speeding up the approval process. Because the eCTD is an international specification, it’s essential to integrate an eCTD solution with your regulatory information management system to ensure your information is standardized for the global market.
2. You Notice Duplicate Documentation
According to the FDA, duplicate documentation is one of the top three rejection categories for eCTD submissions. This can be caused by:
- Submitting revised content under the same sequence number.
- Transferring an application without alerting the new owner of the sequence numbers used.
- Reusing the sequence number of a withdrawn submission.
Rejected eCTD submissions can set back your development cycle by months, if not years. To avoid this problem, you need to watch out for duplicate documentation.
3. Your Conventions Are Not Standardized
Your RIM system manages changes and revisions to dossiers and product information. But if the data conventions aren’t standardized with other functional areas (such as Manufacturing, Clinical and Safety), it can lead to confusion and errors, which slows down the entire development process.
You need to standardize your RIM system’s conventions to ensure the accuracy, completeness and organization of essential documentation.
4. You’re Uncertain About Compliance With the Latest Guidance
Regulatory agencies update compliance standards frequently. Therefore, your RIM system must be flexible enough to submit dossiers based on the latest guidance.
Ideally, your regulatory information management system should identify the production information that global regulatory agencies need and generate compliant submission documents. If yours can’t do that, it’s a sign that you need to optimize.
Conclusion
An unoptimized regulatory information management system can lead to a plethora of compliance problems and rejected submissions. If any of these warning signs sound familiar, it’s time to optimize.
But how? The best place to start is by hiring a regulatory consultant who can help you stay up to date with the latest health authority guidance on electronic submissions, ensure your RIM system is operating at maximum efficiency, and help you understand the processes for which your RIM system supports.
Daelight Solutions partners with pharmaceutical, biotech and medical device companies to optimize RIM systems to streamline information gathering, organization and submission activities. Find out how we can help by contacting us today.