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Choose the pressure point closest to the decision your team needs to make.
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PodcastExpert conversations connecting evidence, judgment, and action.VideoVisual briefings that make regulated systems easier to understand.FAQsConcise answers that orient a regulatory, CMC, quality, or inspection question.
Featured AnalysisThe ICH Q11 Three-Part Justification — What FDA and EMA Require for Starting Material Designation and Where Programs Fall ShortXGene analysis · Aug 22, 2026Read Article →
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Article The ICH Q11 Three-Part Justification — What FDA and EMA Require for Starting Material Designation and Where Programs Fall Short The starting material designation in a drug substance synthesis is one of the highest-stakes decisions in small molecule CMC development — and it is made years before the… 5 min read →

Article FDA Inspection Front Room Protocol — What to Say and What Not To The most consequential decisions during an FDA inspection are not made in the laboratory or on the manufacturing floor — they are made in the first two hours… 11 min read →

Article Salt and Co-Crystal Selection: CMC Documentation of Pharmaceutical Form Decisions in Module 3 Salt selection is the first CMC decision that determines whether your drug will be manufacturable, stable, and bioavailable — and it is a decision made before most of… 4 min read →

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