Thinking from the intersection of science, regulation, and business.

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India's updated classification framework introduces new pathways for IVDs and Class C/D devices. Here's how the revised rules affect your dossier strategy, testing requirements,…

After reviewing dozens of inspection reports from NGCMA and international monitoring authorities, these are the recurring findings that trip up even experienced labs. Practical…

Step-by-step implementation roadmap covering scope definition, method validation, measurement uncertainty, and the NABL audit process.

Beyond the acronym — practical frameworks for embedding ALCOA+ principles into daily lab operations, electronic systems, and training programmes.

Study director access, facility audits, protocol amendments — where sponsor oversight breaks down and how to fix it.

CDSCO vs. state-level licensing, import registration, clinical trial requirements, and local agent mandates explained for international firms.

How to build lean, inspection-ready quality infrastructure without over-engineering for your current stage.

Study directors, QA leads, and test facility managers require structured evaluation beyond standard interviews. Here's how to build the right process.

How AI can preserve institutional knowledge while maintaining the data integrity expectations regulators demand.