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Practical guidance on eCTD, IDMP, controlled vocabularies, and regulatory data strategy.

IDMP eCTD 4.0 SPOR

Why Regulatory Data Still Doesn't Talk to Itself

Over the past month, a recurring theme has cut across otherwise separate pieces of work our consultants have undertaken: Cross-regulatory agency submission classification design, an IDMP interoperability proposal, and a review of how a publishing platform handles controlled vocabulary. Different projects, same underlying fault line — regulatory data architecture is still fighting a fragmentation problem that no single vendor or standard has actually solved.