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 ...

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

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

FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a single uniform identifier across products and trading partners. Linear barcodes ...

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

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

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 ...

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

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

The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication. Outsourcing in the biopharma and pharma industries is on the rise, driven by ...

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.