Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about ...
Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being ...
On March 25, 2026, Merck, known as MSD outside the United States andCanada, announced it has entered into a definitive ...
Domestic manufacturing can improve quality oversight by reducing foreign inspection gaps and enabling early FDA engagement ...
Regulatory pressure from GxP, 21 CFR Part 11, and AI/ML guidance elevates requirements for audit trails, data lineage, ...
The pharmaceutical industry is navigating one of its most disruptive periods in recent memory, according to Anthony Lakavage, ...
France’s Saint‑Julien site adds a bioprocess development suite for upstream/downstream scale-up of recombinant proteins, ...
Richard and David also address pressing concerns around data privacy and IP ownership. Using Google's API allows ...
Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP), outlines the key ...
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
Denis Beckford Vera, head of Radiopharmacology, Champion Oncology advocates clinically relevant PDX models to bridge ...
Global External Affairs, US Pharmacopeia (USP), discusses drug supply chain vulnerabilities tied to China dependence, urging ...
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