Featured Pharma Online Editorial
-
CSV Assumes The AI System Sits Still — It Doesn't.
8/17/2026
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
-
AI Needs Human Oversight To Better GMP Documentation
8/12/2026
In a Pharmaceutical Online Live discussion on building inspection-ready systems with digital documentation, panelists emphasized that AI can accelerate review, trend analysis, and inspection response, but only when governed, validated, and kept firmly under human quality oversight.
-
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
8/7/2026
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
-
6 Reasons Pharma Manufacturing Has Eyes On Puerto Rico
8/1/2026
Several advantages explain why Puerto Rico continues to attract pharma investment, especially as manufacturers reassess supply chain risk and look for options closer to the U.S. mainland.
-
Reshoring Pressure Meets Manufacturing Reality
7/27/2026
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
-
CDMO Live Europe 2026: Partnerships For An Uncertain World
7/27/2026
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
-
Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)
7/13/2026
A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
-
Transforming Computer System Validation In The Life Sciences Industry
7/10/2026
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.
-
Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
7/7/2026
In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.
-
How To Avoid The Biggest USP <665> Compliance Trap
6/30/2026
U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.