Technical Report No. 56 (Revised 2026) outlines a GMP--compliant, phase--appropriate quality management system (QMS) spanning preclinical development through clinical phases and commercial readiness ...

Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Accelerated drug development expertise. For small startups and academic spinoffs bringing their first molecules to market, ...

SEATTLE & HEIDELBERG, Germany--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE ...

The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development process for industry and patients. Our two companies are applying AI in ...

Maria Batalha, Valgenesis, discusses how a centralized digital platform unified drug substance data from R&D to commercial ...

Learn how early coordination across functions, phases and partners can reduce risk and accelerate drug development.

The Congressional Budget Office (CBO) informs Congress about the costs or revenue changes associated with proposed legislation, a challenging enough task on its own. Sometimes, the CBO is asked to ...

A phase 2 trial of Indivior Pharmaceuticals’ opioid use disorder (OUD) candidate has missed its primary endpoint. Indivior ...

The wide range of chromatographic techniques share one common aim: to separate a material into its components. A material, your sample, is dissolved in a solvent, called the mobile phase. This mixture ...