According to Schniepp, inspectors are not auditing the electronic submission mechanism itself because the eCTD system 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 ...

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

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 ...

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 ...

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, Kolter AI, talks on how orchestrator roles surged in pharma AI, but teams need computed plans, not titles, to close the skills gap. Megha Sinha, Kolter AI, discusses how digital twins run ...

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 capability gaps remain unless integrated teams own end-to-end digital ...

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 ...