There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound ...
FDA leadership churn and reported political interference eroded internal cohesion, contributing to resignations of senior career officials and a climate of dysfunction impacting scientific review ...
Learn how to anticipate development bottlenecks early to keep biologic programs on track for first-in-human trials. Hear how to leverage integrated platforms and operational alignment to manage ...
Regionalized early development affects clinical supply, analytical transfer, comparability strategies, and regulatory ...
Reports indicate White House approval to remove Marty Makary, reflecting internal discomfort with political fallout from provocative regulatory shifts and intensifying congressional and ...
Regulatory expectations align across WHO, EU, PIC/S, and Health Canada; US 21 CFR 211.186/211.188 define MPCR content and faithful BPCR reproduction. Inspection trends highlight uncontrolled page ...
This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, ...
Advancing Aseptic Precision: How Modern Filling Lines Elevate Sterility, Flexibility, and Throughput
Isolator-based Grade A/ISO 5 architectures minimize operator interventions, enabling robust contamination control and compliance with EU GMP Annex 1, FDA guidance, PIC/S, and ISO 14644. Lyophilization ...
In this interview, Valerie Bandy, vice president of Pharmacy Solutions, Tecsys, discusses the complex operational realities ...
Vice President Pharmacy Solutions at Tecsys. With a career marked by this steadfast leadership, she has consistently excelled ...
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