Client Overview
A global life sciences organisation, part of a multinational healthcare and technology group, operates across North America with a significant international presence. With a portfolio exceeding 300,000 products, including antibodies and companion diagnostics (CDx) markers, and a presence in more than 65 countries, the organisation manages large-scale regulatory documentation in a highly complex and regulated environment.
Background
With the implementation of EU IVDR (2017/746), the client faced increasing pressure to strengthen documentation processes across a large diagnostic portfolio. The requirement extended beyond producing compliant reports to maintaining consistency, accuracy, and traceability across hundreds of documents and recurring annual updates.
As documentation volumes grew, so did the complexity of aligning with evolving regulatory expectations, particularly across performance evaluation and post-market surveillance reports
Services in Scope
End-to-end authoring of Clinical and performance documentation (CPR, PMPF, APR, SVR, and SOTA)
Development of PSUR and PMSR for post-market compliance
Annual updates across all document types
Alignment with evolving IVDR requirements
Support for high-volume, multi-product documentation
Challenge
The client was managing a high volume of IVDR documentation, with each report expected to be delivered within a tight two-week timeline.
However, sustaining this at scale proved difficult. Annual updates required repeated validation of historical data, literature references, and citations, often triggering multiple review cycles before finalisation.
Inconsistencies across documents led to rework, delaying reviews and creating bottlenecks in the overall workflow. As volumes increased, these inefficiencies compounded, placing additional pressure on internal teams and extending turnaround timelines.
Teams were spending significant time reconciling data, aligning document versions, and addressing review feedback, limiting their ability to focus on higher-priority deliverables and product-level quality
Solution
1
Freyr restructured the documentation process by introducing a first-time-right delivery model designed to handle high volumes without compromising quality.
2
The approach focused on standardization across the portfolio rather than treating each document independently. IVDR-aligned templates ensured consistency, while parallel authoring and review workflows enabled multiple reports to progress simultaneously.
3
Quality controls were embedded throughout the lifecycle instead of being applied at the end, allowing issues to be identified and resolved early. At the same time, structured validation of literature and citations improved traceability and reduced inconsistencies during reviews.
4
This shift transformed documentation from a sequential, rework-heavy process into a streamlined and scalable delivery model capable of consistently meeting aggressive timelines.
Impact
Freyr transformed a resource-intensive, iteration-heavy documentation process into a scalable and high-efficiency delivery model, delivering measurable improvements in speed, quality, and operational effectiveness.
Consistent ~2-week delivery per document, even across 1000+ IVDR performance evaluation reports
40% reduction in turnaround timelines, accelerating validation and submission readiness
Zero critical quality errors, ensuring first-time-right delivery across all reports
Significant reduction in review cycles and rework, improving efficiency and throughput
Accelerated regulatory readiness and submission timelines across a large diagnostic portfolio
Reduced internal resource dependency and optimised costs, enabling focus on priority deliverables