BMS will deploy NVIDIA DGX Vera Rubin NVL72, citing up to 10× performance per megawatt versus prior architecture, enabling larger models without proportional energy growth. Expanded compute is ...
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 ...
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.
Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.
Megha Sinha, Kolter AI, discusses how digital twins run pharma supply chains but miss the regulatory execution needed to launch changes across markets.
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 ...
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