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 ...

A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving FDA visibility through required pre-notification of unit relocation and ...

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

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

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.

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

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 ...

Annex 1 is driving investments in HVAC, water/clean utilities, environmental monitoring, barrier technologies, and facility remediation, with true maturity defined by QRM altering capital ...