Regulatory updates, GMP compliance, formulation technology, and exhibition news — written by our regulatory and manufacturing teams for distributors, hospital procurement officers, and pharmacy chain buyers in 60+ countries.
A landmark ANDA approval reshapes supply for one of the most-prescribed antibiotics. We break down the dossier, the manufacturer, and how distributors should plan their Q4 inventory.
From gap analysis to eCTD submission — a practical checklist distilled from 40+ country filings, with module-by-module tips for oral solid dosage and injectables.
Three days, 180 meetings, and a clear signal: pharma buyers are consolidating suppliers. Our take on the moves that matter and the SKUs that drew the most inquiries at our booth.
Wet granulation vs. direct compression, when to use each, and how process controls directly affect dissolution profiles. A visual walkthrough of our three EU-GMP lines.
The revised Annex 1 raises the bar for contamination control strategy, A-grade monitoring, and pre-use post-sterilization integrity testing. Here’s a pragmatic 12-month action plan.
PQ is the gateway to UN agency tenders and most African & Asian government procurement. We share the real timeline, the common pitfalls, and the cost drivers from 12 finished PQ projects.
From WHO PQ vs. local registration to incoterms and payment security — the five most-asked questions at our Cape Town booth, with detailed answers for new African distributors.
Why terminal sterilization remains the gold standard for cephalosporins, and how a robust Aseptic Process Simulation (APS) program is non-negotiable for aseptically-filled injectables.