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Drug manufacturing process. Conveyor with medical ampoules line at a modern pharmaceutical plant. Pharmacology production, medicine industry from laboratory 2 factory, pharmacy. Healthcare, pharma 3D | Image Credit: © Corona Borealis - © Corona Borealis - stock.adobe.com
PDA 2025: How Strategic CAPA Builds Anti-Fragile Manufacturing Compliance

September 11th 2025

Optimizing FDA 483 responses with strategic CAPA creates resilient quality compliance in biopharma manufacturing.

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images - stock.adobe.com
FDA Enables Instant Access to CRLs—Insights for Drug Discovery and Manufacturing

September 5th 2025

Doctor technology AI integrates big data analytics with clinical research, enabling precise treatment plans tailored to individual patient needs and genetic profiles. | Image Credit: © Suriyo - stock.adobe.com
Agentic AI Collaborative Initiative Announced by Pistoia Alliance

September 4th 2025

Red and white blood cells and in the vein | Image Credit: © Tatiana Shepeleva - © Tatiana Shepeleva - stock.adobe.com
FDA Fast Track Designation for VMX-C001 Highlights Need for Improved Anticoagulant Reversal

September 4th 2025

Industry inspector team working, QC staff work checking machine operation for safety and hygiene | Image Credit: ©Quality Stock Arts – stock.adobe.com
New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

August 29th 2025

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Digitalization of QbD Risk Assessments; Image: photon_photo  - stock.adobe.com
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