Latest Developments and Insights
Managing Complexity: How Strategic Execution Drove a Cleanroom Upgrade Project to Completion
Every complex project has its challenges, but some redefine what challenge means. The cleanroom re-classification “Cleanroom Upgrade” project stands as a testament to how strategic execution, relentless problem-solving, and cross-functional teamwork can turn a nearly stalled initiative into a success.…
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Building a QMS (Quality Management System) for Medical Device
Bringing a medical device to market requires more than innovative design and clinical excellence, it demands a robust, compliant Quality Management System (QMS). ISO 13485:2016 and various regional regulations, such as the FDA’s new Quality Management System Regulation (QMSR), mandate…
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Manufacturing Gaps in the U.S. Pharmaceutical Industry Exposed by Tariff Wars
The pharmaceutical supply chain is a globally interdependent network—one that has long relied on international trade to maintain affordability, innovation, and access. However, the intensification of tariff wars—particularly between the United States and countries like China, India, and Canada—is exposing…
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The Real Cost of Uncertainty: Why On-Again, Off-Again Tariffs Hurt Biotech Supply Chains
In drug development, and especially for smaller and medium-sized biotech companies, consistency is everything. From regulatory pathways to R&D timelines to global supply chains — predictability enables progress. But there’s one growing source of disruption that biotech leaders are increasingly…
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Accelerating a Cytotoxic Peptide-Drug Conjugate to IND: A Medicinal Chemist’s Journey to IND with Syner-G BioPharma Group
As a medicinal chemist with experience in large pharmaceutical companies, I’ve spent my career designing and optimizing drug candidates. But when I was tasked with advancing a highly potent cytotoxic peptide-drug conjugate (PDC) toward IND submission, I found myself in…
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Navigating Analytical Method Comparability and Equivalency Under ICH Q14: A New Era for Analytical Procedure Lifecycle Management
The landscape of analytical development is continually evolving. With the introduction of ICH Q14: Analytical Procedure Development, the pharmaceutical and biotech sectors now have a formalized framework to guide the creation, validation, and lifecycle management of analytical methods. To keep…