There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound ...

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 ...

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 ...

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, ...

As a critical raw material for our manufacturing operations, media and buffers sit at the heart of the supply chain. On the ...

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 ...

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the ...