Blog — Insights & Updates

Software Solutions & ServicesMay 13, 2026 3 min

AI in Life Sciences: From Hype to Compliant Reality

Discover why governance, validation, and trust, not model performance, are the real challenges for AI adoption in life sciences.

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Software Solutions & ServicesMay 13, 2026 4 min

Why AI Is Too Generic for Regulatory Conversations in Life Sciences

Discover why AI governance in life sciences depends on intended use, risk context, and control frameworks rather than the AI label itself.

ToxicologyRegulatory AffairsMay 6, 2026 4 min

Bringing ERA into Practice: Key Challenges in Pharma

Discover the practical challenges of Environmental Risk Assessments (ERAs) in pharma, from toxicology input to data consistency and lifecycle management.

Regulatory AffairsMay 6, 2026 5 min

Governance in Combined Studies: Getting Roles Right Before the Clock Starts

Discover why governance and role clarity are critical in combined drug-diagnostic studies under the CTR and IVDR.

Regulatory AffairsMay 6, 2026 4 min

Why Pharma and IVD Partners Must Collaborate Earlier Than You Think

Discover why early collaboration between pharma sponsors and IVD partners is critical for successful companion diagnostic development under the IVDR.

Regulatory AffairsMay 6, 2026 4 min

The Harmonisation Gap: Managing EU Performance Study Submissions

Discover why IVDR performance study submissions remain fragmented across Europe and how regulatory differences impact timelines and study strategy.

Regulatory AffairsMay 6, 2026 5 min

No Shortcuts: Why In-House Devices Under Article 5(5) Are Not the Easy Route

Thinking Article 5(5) is the easy route under the IVDR? Discover the hidden obligations and risks of in-house devices.

Regulatory AffairsMay 6, 2026 4 min

When Does Your Diagnostic Become an IVD in a Clinical Trial?

Discover when an assay used in a clinical trial falls under the IVDR and what this means for timelines, compliance, and study strategy.

Software & Digital HealthApr 29, 2026 3 min

A 7-Phase Framework for AI/ML Compliance in Life Sciences

Discover a 7-phase AI/ML compliance framework for life sciences, covering data governance, validation, and post-launch monitoring under GxP.

Software & Digital HealthApr 29, 2026 3 min

What Pharma Can Learn from MedTech's AI Validation Playbook

Pharma is still figuring out AI validation. MedTech already solved it. Learn what to copy from MedTech's proven playbook to ensure GxP compliance and real-world impact.