Contributing Editors
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Lessons In Quality From Sanofi's Plai.qa
11/24/2025
The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.
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Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
11/21/2025
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
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Here's What You Need To Know About The Access Consortium Pathway
11/20/2025
Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.
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Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
11/18/2025
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
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How To Improve Sponsor–CMO Collaboration Around Digital Deviations
11/17/2025
Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.
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Global Implications Of Zero Tariffs On Indian Pharma Exports To China
11/5/2025
Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.
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M&A In GLP-1 Technology: Practical Recommendations And Best Practices
11/4/2025
With explosive demand, expanding indications, and rapid innovation, the GLP-1 revolution is reshaping dealmaking. Here's a practical guide for companies negotiating M&A in this arena.
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Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
10/31/2025
The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.
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The Transition To E-Labeling Is More Than Uploading PDFs
10/31/2025
Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.
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Are You Still Evaluating CMOs When You Really Need A CDMO?
10/29/2025
Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.