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

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 ...

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

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

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

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 ...

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

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

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

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.

Manufacturing digitalization is expanding via MES, eQMS, automation, and data-integrity initiatives, yet cross-functional ...