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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 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 MIN