Kent Malmros is senior director of training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life-sciences companies and has held ...

AI tools have arrived, but organizational readiness, data governance, and regulatory gaps now limit real-world impact. Six months after industry experts laid out their predictions for 2026, many of ...

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

Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for ...

Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...

Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026. This month in pharmaceutical regulations, in the United States, the FDA ...

Revised recommendations address manufacturing-source submissions, immunogenicity-related testing, impurity thresholds, higher-order structure analyses, and bioactivity assessment, tightening the ...

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Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control. Pharmaceutical manufacturing is entering a phase ...

Cheryl Barton, a contributing writer for PharmTech Europe, highlights how European biotechs are using AI-driven target discovery to push respiratory treatment beyond broad immunosuppression toward ...

Leading manufacturers now deploy validated agentic AI that detects OOS events, retrieves batch records, correlates prior deviations, and drafts RCA packages, yielding ≥50% faster investigations.