Contributing Editors
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A Road Map For Transitioning From A Research-Focused To Commercialization Mindset
6/3/2025
As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?
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Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations
6/2/2025
The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).
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Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis
6/2/2025
Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.
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Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services
5/22/2025
The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?
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Lilly's Calculated Approach To Upgrade Trade-Offs
5/22/2025
If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.
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What Patients Say Matters: How AI Analyzes Sentiment to Improve Generic Drug Oversight
5/22/2025
Employing multiple AI models to analyze public sentiment of generic drugs minimizes bias and enhances reliability. This makes AI a proactive tool for pharmaceutical quality assurance.
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First AMT Program OK'd Under New FDA Designation — Here's What To Know
5/21/2025
The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.
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How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities
5/20/2025
A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.
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Small Molecule Pharma Companies Are Employing These Advanced Technologies To Get Ahead
5/19/2025
Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.
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The 3 Phases of QRM – An Inspector's View
5/14/2025
Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.