Life Sciences Blog

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.

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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.

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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.

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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.

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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.

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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.

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Regulatory AffairsApr 29, 2026 3 min

The Hidden Operational Hurdles of EU Market Entry

CE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.

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Regulatory AffairsApr 29, 2026 3 min

Why Clinical Strategy Is the Real Bottleneck for EU Market Access

Discover why clinical strategy, not data, is the real bottleneck for EU MDR market access and how to align regulatory and clinical decisions.

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Regulatory AffairsApr 29, 2026 3 min

Clinical Evidence Under EU MDR: What Non-EU Manufacturers Get Wrong

Discover what non-EU manufacturers get wrong about clinical evidence under the EU MDR, from CER requirements to PMCF and data reuse.

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Regulatory AffairsApr 29, 2026 3 min

The EU Notified Body Process: What Every Non-EU Manufacturer Should Know

Understand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR.

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Regulatory AffairsApr 29, 2026 2 min

Why FDA or NMPA Approval Does Not Mean You're Ready for Europe

FDA or NMPA approval doesn't guarantee EU readiness. Discover the key gaps MedTech companies face when transitioning to EU MDR.

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Regulatory AffairsApr 14, 2026 5 min

EU and UK Regulatory Submissions: Platforms, Authority Interactions and Timeline Control

Entering Europe after FDA approval? Learn how to manage EU and UK regulatory submissions, authority interactions, and submission timelines efficiently.

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Regulatory AffairsClinicalApr 13, 2026 4 min

First-in-Human Operational Readiness for Emerging Biotechs: The Minimum Framework You Need

Prepare for First-in-Human trials with the right operational framework. Align safety, governance, and clinical execution to meet regulatory expectations.

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