Megha Sinha, Kolter AI, discusses how pharma's AI bottleneck shifted from technology to readiness as execution across 60 ...

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 ...

Novo Nordisk challenges nationwide Zepbound/Mounjaro advertising as misleading comparative promotion, citing omitted disclosure of the most effective FDA-approved semaglutide injectable doses. One ...

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 ...

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 ...

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 ...

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 ...

A 2026–2027 joint work program operationalizes EMA–EISMEA cooperation to move European Innovation Council-funded projects toward regulatory-compliant medicines and health technologies. Targeted ...

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