EMA Policy 70 has expanded significantly, requiring broad publication of clinical data to increase transparency and public trust. This article explains what the revised policy means, the challenges companies face when preparing redactions, and how organizations can turn compliance into a strategic advantage.
DevOps offers faster delivery and collaboration, but in regulated GxP environments it must be adapted for traceability and control. This Insight explores how pharmaceutical companies can integrate QMS and DevOps to achieve true continuous delivery.
Artificial intelligence is reshaping life sciences, but expectations often exceed reality. Success requires strong data foundations, governance, and compliance. Learn how companies can move from AI hype to practical value, turning innovation into measurable results while reducing risk and ensuring regulatory alignment.
As demand for biologics surges, biopharma manufacturers face a critical hurdle: scaling operations amid a growing talent shortage. In Denmark and across the Nordics, a lack of specialized expertise slows tech transfer, validation, and regulatory readiness. Discover a three-tiered solution—training, coaching, and expert support—to scale with confidence.
Data migration in life sciences is no longer a one-time headache—it’s becoming a continuous, AI-assisted capability. Learn how life science organizations are moving from disruptive, high-risk projects to repeatable, GxP-compliant data pipelines that keep systems updated and insights flowing. Ready to make migration part of your digital routine?
This Insight explores the impact of EcoVadis Ratings on procurement decisions in the life sciences. Director of Sustainability, Communications, and Culture @Naomi Jade Kellogg breaks down why EcoVadis matters, how it’s shaping procurement, and what suppliers can do to boost their ratings and stay ahead.
Pharma IT Insights Drug-Device Combination Products and the Impact of the EU MDR By Anne Louise Kirkegaard February 9, 2025 Pharma IT Insights Drug-Device Combination Products and the Impact of the EU MDR By Anne Louise Kirkegaard February 9, 2025 ← Back to Insights Share on email Share on linkedin Share on facebook Share on …
This Insight is part of our AI in Pharma Series, where we share use cases for AI & automation in a highly regulated reality. With the ongoing migration from the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) to the Product Management Service (PMS), companies face the added challenge of ensuring seamless data integration and synchronization. In this Insight, we delve deeper into the challenges of meeting these regulatory demands and present an automated AI solution to solve them.
This Insight, written by Pharma IT Director of Regulatory Affairs (RA) Anne Louise Kirkegaard, highlights the importance of a solid RA strategy for small pharma and biotech companies. Plus tips to ensure market success and compliance.
This Insight, written by Pharma IT Cybersecurity expert Steen Lindebjerg provides a high level overview of the EU’s NIS2 Directive, including key changes in the old NIS legsilation and steps to take towards compliance.