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SOPs for Temperature-Sensitive Pharma Products Logistics

The Foundation of Temperature-Controlled Pharmaceutical Logistics The pharmaceutical industry operates under stringent regulations where maintaining product integrity throughout the supply chain is paramount to patient safety and therapeutic efficacy. Standard Operating Procedures (SOPs) for handling temperature-sensitive pharmaceutical products represent the...

Optimizing DMF Quality for Successful Health Authority Filings

A Drug Master File (DMF) is a confidential regulatory submission that provides comprehensive, precise, and accurate data about an Active Pharmaceutical Ingredient (API) or a Finished Product Dosage Form (FP). It encompasses critical information on the manufacturing process, quality...

Evolution of Regulatory Frameworks for Real-World Data

The pharmaceutical landscape has undergone a profound transformation as regulatory agencies worldwide embrace real-world data to support drug development and approval processes. This regulatory navigation real-world data paradigm requires pharmaceutical companies to master complex frameworks that balance scientific innovation...

The Way Forward for the Healthcare Data Ecosystem

The transformation of worldwide healthcare by way of digital innovation has reached a very critical inflection point in which the potential advantages of data-driven medicine should be carefully balanced against the fundamental ethical principles as well as privacy rights....

$2 Billion Expansion By J&J in North Carolina Facility

Johnson & Johnson on August 21, 2025, went on to announce that it will be adding another 160,000 ft.² dedicated manufacturing facility in its Fujifilm site based at Holly Springs, NC. This is going to be a part of...

Pharma Sector Reactions to US-EU Trade Framework Deal

The United States and the EU have, on August 21, 2025, announced a joint statement related to the trade framework agreement on reciprocal, fair, and balanced trade. This landmark trade US-EU trade framework agreement happens to mark a major...

Trump Executive Order to Cover 26 Drugs Critical to Health

US president Donald Trump has gone on to direct the health department to draw a list of drugs that are deemed to be essential and stockpile the active pharmaceutical ingredients (APIs) that they require. His executive order is going...

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