Pharmaceutical manufacturing laboratories must maintain reliable data, controlled processes, and regulatory readiness while supporting efficient quality operations. This white paper examines how a purpose-built, pre-validated LIMS can replace manual and disconnected workflows with integrated sample management, instrument connectivity, secure audit trails, and embedded quality-management capabilities. Learn how a modern LIMS can help improve data integrity, streamline laboratory operations, support compliant batch release, and protect 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.