Regulations & Compliance
-
FDA’s 2025 New Rules That Could Shut You Down
read more >>: FDA’s 2025 New Rules That Could Shut You DownFDA’s 2025 new rules. If you’re in pharmaceutical distribution, you already know the FDA doesn’t send a friendly memo before turning your compliance strategy upside down. And with the 2025 FDA changes for pharmaceutical distributors rolling in, the stakes just got higher. I remember the first time an FDA audit caught one of my clients…
-
Why GDP Compliance Is the #1 Survival Factor for Modern Pharma Distributors
read more >>: Why GDP Compliance Is the #1 Survival Factor for Modern Pharma DistributorsIn today’s unforgiving pharmaceutical landscape, GDP compliance is no longer a box to check—it’s the make-or-break standard that defines operational survival and brand trust. Good Distribution Practice (GDP) has become more critical than manufacturing quality itself. A 2024 industry report found that 68% of drug recalls are now traced back to distribution failures, costing companies…
-
How to Effectively GDP Implement in Your Pharma Supply Chain
read more >>: How to Effectively GDP Implement in Your Pharma Supply ChainGood Distribution Practice (GDP) compliance is mandatory in the pharmaceutical industry. Yet, a surprising 47% of distributors still fail inspections—not because of the lack of documentation, but due to the gap between written policies and real-world execution. This practical implementation guide is designed to help pharmaceutical companies move beyond compliance on paper and embed GDP…
-
GDP Compliance 2025 Checklist: The Ultimate Checklist for Pharma Distributors
read more >>: GDP Compliance 2025 Checklist: The Ultimate Checklist for Pharma DistributorsWhy GDP Compliance Just Got Tougher in 2025 GDP Compliance 2025. The European Union’s updated Good Distribution Practice (GDP) 2025 guidelines introduce stricter requirements for pharmaceutical distributors. With 40% more inspections expected this year and fines up to €500,000 for violations, compliance is no longer optional—it’s business-critical. This ultimate checklist covers every requirement your distribution…
-
FDA Drug Distributor Registration: Avoid These 5 Common Rejection Reasons
read more >>: FDA Drug Distributor Registration: Avoid These 5 Common Rejection ReasonsWhy Proper Registration Matters More Than Ever FDA Drug Distributor Registration. The FDA rejected 17% of first-time FDA drug distributor applications in 2023 – a rate that’s doubled since 2020. With increased scrutiny under DSCSA enforcement, your registration packet must be perfect. One error can trigger 30-90 day delays and put your distribution business at…
-
2025 Pharma Distribution License Requirements: What’s New & What You Can’t Miss
read more >>: 2025 Pharma Distribution License Requirements: What’s New & What You Can’t MissThe pharmaceutical industry is one of the most tightly regulated sectors globally. As we approach 2025, staying compliant with the latest pharma distribution license requirements is more critical than ever. With new regulations and digital transformations underway, companies must be fully prepared to adapt—or risk penalties, delays, and reputational harm.In this article, we’ll explore the…