Curious Quill·Sep 15Hot Melt Extruder Performance in Solid Dispersion Development: A Lab-Scale PerspectiveOral bioavailability is one of the most persistent challenges in small-molecule drug development. When an active pharmaceutical ingredient…
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 icon2
Mahtab Shardi·Aug 10Pharma Regulation Is Changing Fast in 2026, 7 Shifts Quality Teams Can’t IgnorePharmaceutical regulation in 2026 is changing faster than many quality systems can adapt.A response icon1
Mahtab Shardi·Jul 27Most Companies Misunderstand EU GMP Annex 11, Here’s What Inspectors Actually Look ForEU GMP Annex 11 governs computerized systems that support GMP-regulated pharmaceutical work. It covers software and hardware used in…
Mahtab Shardi·Jun 29Reading EU GMP Annex 1 Isn’t Enough, Here’s What Experienced GMP Teams Read Next“I’ve read Annex 1 three times, but I still don’t know how to build a Contamination Control Strategy.”
