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Company Background Lonza is a Swiss-headquartered contract development and manufacturing organization (CDMO) that partners with pharma and biotech companies worldwide....
This whitepaper is the final part of a two-part series on the use of AI in regulated industries. It explores...
AI is reshaping quality management, but in life sciences and other regulated industries it must be proven to be reliable....
Australia and New Zealand are introducing changes that will significantly impact life sciences companies for 2026. Australia’s reforms include new...
Electronic Batch Records (EBRs) have become essential for modern pharmaceutical and life sciences manufacturing. While many systems promise compliance and...
As Asia’s life sciences regulatory landscape evolves in 2026, companies face significant changes that demand strategic preparation. India is piloting electronic Common...
The European Medicines Agency (EMA) is at the forefront of digital transformation in pharmaceutical regulation through its Digital Application Dataset Integration (DADI) project. This...
By incorporating ISO 13485:2016 principles and ISO 9000:2015 references, the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) aims to...
An Enterprise Quality Management System (eQMS) serves as the cornerstone for organizations striving to achieve excellence in quality and compliance, enabling businesses to make...
