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Regulatory intelligence.
Guideline changes, submission-window updates and practice notes from TMDA, TBS and the EAC — written by the desk that files there every week. Read it here before it reaches your inbox as a query letter.
New eCTD validation criteria: what changes for importers from July
The updated technical validation checklist tightens Module 1 metadata. Here is what fails screening now — and how to fix it before you submit.
READ — 6 MINOne dossier, six regulators: using the EAC joint assessment well
The harmonised procedure can cut months off multi-country registration — if your dossier is structured for it from day one.
READ — 8 MINYour obligations don't end at authorisation. Neither does our work.
Post-marketing surveillance requirements in Tanzania, explained — and the reporting calendar every marketing authorisation holder should keep.
READ — 5 MINGMP inspection findings we keep seeing — and how to close them early
Five recurring observations from recent site inspections, with the remediation evidence inspectors actually accept.
READ — 7 MINPaper registers are a compliance risk: digitising pharmacy records properly
What the law requires of dispensing records, and how to move them into software without losing audit history.
READ — 6 MINChoosing your first EAC market: a decision framework for new entrants
Tanzania, Kenya or Rwanda first? The registration mathematics behind the market-entry order.
READ — 9 MIN