Notes from the field on regulatory updates, market access, pharmacovigilance, and quality management — written by the people who actually do the work.
From January 2025, oncology medicines and ATMPs entering the EU face a new mandatory joint clinical assessment under the Health Technology Assessment Regulation. We unpack the practical consequences for manufacturers filing in the Western Balkans — and how to sequence the EU and national submissions without duplicating effort.
Read the full analysis →An honest walkthrough of the three findings we received, what we changed in our Q3–Q4 procedures, and how we prepared for the next inspection cycle.
How we validated thermal packaging for ambient shipments crossing 40°C highways — and the simple field test that caught a packaging supplier defect.
An updated table of reimbursement timelines, HTA requirements and tender cadence for each of the markets AMDIS serves — useful for any manufacturer planning regional launch.
Reflections on the practical impact of the UK's MHRA decoupling from EU QP certification, and what it means for products distributed into both EU and UK markets.
A pragmatic look at serialisation and verification across 14 markets — three years in, what's working, what's still painful, and what the next regulatory wave will look like.
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