According to Schniepp, inspectors are not auditing the electronic submission mechanism itself because the eCTD system is already validated, and paper submissions are essentially obsolete in both the ...

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 ...

Pharmaceutical Technology Europe | Publications | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market. Some of ...

Regulatory Optimisation Group efforts are converging on a future-state lifecycle change process, shifting from document-based ...

Megha Sinha, founder and CEO of Kolter AI and Kamet Consulting Group, spoke with PharmTech at the beginning of 2026 about her ...

Jay Lichtenstein | Authors | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

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 ...

Pharmaceutical Technology | Publications | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

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.

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