This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report ...

Megha Sinha, founder and CEO of Kolter AI and Kamet Consulting Group, spoke with PharmTech at the beginning of 2026 about her ...

Regulatory Optimisation Group efforts are converging on a future-state lifecycle change process, shifting from document-based ...

USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...

A 2026–2027 joint work program operationalizes EMA–EISMEA cooperation to move European Innovation Council-funded projects ...

Kolter AI, discusses how digital twins run pharma supply chains but miss the regulatory execution needed to launch changes ...

In part 1 of a 3-part interview, Brent Wilhelm, Senior Vice President of Global Supply Chain, Cencora, brings more than 30 years of healthcare industry experience to a role focuse ...

A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving ...

Cencora, discusses why pharma supply chains still run on historical demand data and how AI could close the real-time visibility gap.

Economic asymmetry after cartridge introduction drives a design philosophy centered on minimizing false acceptances and protecting API, with >99.5% first-pass yield as the principal success criterion.

Fragmented plant data across silos drives late investigations and corrective action; connected architectures unify PAT, sensors, batch, quality, and maintenance signals to enable earlier risk ...