Why Health Authorities Are Watching How You Build Your eCTD — Not Just What You Submit If you’re still thinking of eCTD publishing as a “just make it valid” checkbox, you’re missing a critical shift in health authority expectations. The days of agencies simply validating your XML against a DTD and moving on are rapidly […]
Beyond Controlled Vocabulary: The Case for Regulatory Reasoning For decades, our industry has grappled with the challenge of consistent, compliant data. The solution, for a long time, was the controlled vocabulary. And don’t get me wrong, it was a massive leap forward. Before controlled vocabulary, we faced metadata chaos – free-text fields, endless variations for […]
