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 ...

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

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 ...

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

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 ...

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

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.