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2 min read
In the life sciences industry, the push for digital transformation has placed regulatory submission automation at the forefront. The promise is faster submissions, reduced costs, and improved accuracy. While automation can deliver significant returns, the path to successful implementation is fraught with potential challenges. Freya. Fusion, Freyr’s AI first cloud-based RIMS platform has helped multiple customers reduce their NDA submission times from 90 days to just 30, saving 1000’s of man hours.
Simply purchasing a tool is not enough. Without a strategic approach, companies risk investing in solutions that create more problems than they solve. Here are four common pitfalls in regulatory submission automation and how a partnership-driven approach can help you navigate them.
Focusing on Technology Over Process:
One of the most significant mistakes is implementing automation on top of inefficient or non-standardized workflows. If your current processes are complex and inconsistent, automating them will only amplify the chaos. This leads to poor user adoption, duplicated data entry, and a fragmented view of your regulatory landscape.
- The Solution: True automation success starts with a solid foundation. Before introducing any new technology, it's crucial to streamline and harmonize existing processes. A successful partner will help you establish a clear framework, define KPIs, and implement quality-driven checklists to ensure your team and technology are aligned. At Freyr, we address this by identifying process gaps at the outset and implementing a "Train the Trainer" model to ensure seamless adoption.
Creating Disconnected Data Silos:
Many organizations adopt multiple point solutions for different regulatory functions—one for document management, another for publishing, and a third for tracking. This fragmented approach creates data silos, preventing a unified view of your product lifecycle and hindering effective decision-making.
- The Solution: A unified, AI-first cloud platform is essential for breaking down these barriers. By leveraging a solution with a harmonized common data model, all regulatory functions can operate from a single source of truth. Freyr's Freya.Fusion platform, for example, provides end-to-end transparency, enabling better insights and ensuring data and content can be seamlessly reused across submissions.
Underestimating Regulatory and Project Volatility:
The regulatory environment is anything but static. Guidelines change, submission volumes fluctuate, and last-minute document updates are inevitable. A rigid automation system that can't adapt to this volatility will quickly become a bottleneck, leading to missed deadlines and non-compliance.
- The Solution: Your automation strategy must be built for flexibility. This includes having a delivery model that offers 24/7 global coverage and maintains a bench of reserve resources for rapid scalability. Freyr mitigates this challenge by building in operational flexibility, with a dedicated "Red Alert Team" and a 3-shift model to manage urgent submissions and ensure on-time delivery, even with unexpected changes.
Adopting a 'One-Size-Fits-All' Tool:
Global life sciences companies manage submissions across dozens of health authorities, each with unique requirements. A generic automation tool that doesn't support regional nuances or specific submission formats (e.g., eCTD, NeeS, paper) will fall short, forcing teams into manual workarounds that defeat the purpose of automation.
- The Solution: Choose a partner with proven, configurable technology and deep domain expertise. Your publishing solution should support a wide array of global health authority templates out-of-the-box. Our Freya.Submit platform is designed for this purpose, supporting formats for the FDA, EMA, Health Canada, PMDA, and many others, ensuring compliance no matter where you're submitting. Furthermore, with flexible sourcing options like managed services, unit-based or project-based support, you can tailor the solution to your organization's specific needs.
Conclusion
Successful regulatory submission automation is about more than just software—it's about partnering with experts who understand the complexities of the global regulatory landscape. With a track record of over 250,000 submissions and a 99% right-first-time quality metric, Freyr provides the deep subject knowledge, proven technology, and operational flexibility needed to turn the promise of automation into a reality.
Ready to avoid the pitfalls and accelerate your submissions? Contact Freyr today to learn how our end-to-end automation solutions can transform your regulatory operations.
