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Why Compliance Matters in the Pharmaceutical Industry
In the pharmaceutical world, compliance isn't just a regulatory checkbox, it's the backbone of patient safety, product quality, and industry trust. Every capsule, vial, and tablet that reaches the public has been shaped by a set of rules designed to protect health. When those rules are ignored, the consequences are serious: unsafe medicines, recalls, fines, and reputational damage that can take years to repair. A Member of Personnel Filling Out Documentation. More Than a Lega
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Nov 27, 20253 min read
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Compliance Risks in 503B Outsourcing Facilities
Outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act were meant to fill an important gap in patient care: producing compounded sterile preparations at scale, under current Good Manufacturing Practice (cGMP). But in the past year, FDA warning letters to several 503B facilities show how fragile compliance can be, and how quickly lapses in quality and sterility assurance place patients at risk. 3D Illustration of Bacteria. Sterility As
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Nov 20, 20253 min read
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Cosmetics Compliance in 2025: A Practical Roadmap for EU, UK, and US Brands
Cosmetic regulation tightened considerably over the past few years, and 2025 is very much a "show your work" moment. Whether you operate in the EU, UK, or US, authorities now expect clear evidence that you know what's in your products, how they're made, and how you monitor safety once they're on the market. Below is a concise, jurisdiction-by-jurisdiction playbook, with the essential documents and actions you should have in place. Man Filling Out Compliance Paperwork. Europea
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Nov 12, 20254 min read
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