Anna Smith·1d ago340B Integrity at Scale: Connecting Detection, Investigation, and Evidence340B purchases reach $100 billion, manufacturers need a reviewable way to connect data, investigate potential issues, and substantiate what…
Mahtab Shardi·Nov 2FDA 21 CFR Compliance: Why Signed Records Can Still Leave Critical GapsEvery SOP is approved. Every batch record is complete.Every required signature is in place. So why might the release decision still be…
Creaton Poh·Oct 28Can a GMP Factory Use Generative AI in Production?Europe’s draft GMP annex on artificial intelligence draws a line every regulated factory should read: generative AI stays out of decisions…
Mahtab Shardi·Oct 12Pharmaceutical Risk Assessment Isn’t Just Paperwork: What GMP Teams Must ProveThe risk assessment is approved, every box is checked, every signature is in place, but can anyone prove the controls work?
Mahtab Shardi·Oct 5Your Pharmaceutical Risk Assessment May Look Complete, That Does Not Mean the Risk Is ControlledMost pharmaceutical risk assessments fail long before anyone enters a number into a matrix.
The Opinion Board·Oct 2Why Is Everyone on Ozempic More Than Weight LossThe drug that accidentally exposed the broken science behind addiction, inequality, and a healthcare system that profits from keeping…
Gavin Shou·Sep 23Can Peripheral Restriction Give CB1 a Second Chance in Obesity?What CRB-913 may tell us about revisiting an old obesity target through tissue-selective pharmacology
Rafik Dimian·Sep 3Loss of Exclusivity Is Not the End of a Product. It Is a Portfolio Decision.In the pharmaceutical industry, few dates attract as much attention as Loss of Exclusivity, or LOE.
Yogen·Sep 2The Billion-Dollar Extraction from Human VeinsHow human plasma became the raw material for a vast pharmaceutical industry.
Mahtab Shardi·Aug 24Can the FDA Inspect a Pharma Site in Toulouse? Here’s How GMP Really WorksWhat happens when a pharmaceutical site in Toulouse manufactures for both Europe and the United States? Which GMP rules actually matter and…A response icon2A response icon2
