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 ...

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

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.

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 ...

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.

High-concentration injectable formulations present unique challenges. Poor solubility issues are often associated with small-molecule APIs formulated for oral administration. Solubility is also ...