This piece of content details how LabVantage Pharma LIMS serves pharmaceutical manufacturers with built-in compliance, speed, and quality assurance. It describes a pre-validated, purpose-built platform that supports FDA 21 CFR Part 11, EudraLex Annex 11, and GxP standards. The system enables rapid deployment (go-live in ~90 days), automated workflows, instant Certificates of Analysis, and robust security. Labs can simplify operations, strengthen compliance, and accelerate batch release while safeguarding product quality.
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.