INSIGHTS ON REGULATORY COMPLIANCE
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How CMOS/CDMOS Drive Industry Growth
From minimizing costs and accessing advanced tech to speeding market entry, dive into how outsourcing drug development and manufacturing to CMOs/CDMOs offers strategic advantages.
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Development Of Improved Chromatographic Methods
Explore the evolving role of GLP-1 agonists in weight management and diabetes care, and discover the urgent need for advanced chromatography methods to ensure pharmaceutical quality and safety.
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Navigating Regulatory Expectations For Injectable Packaging
Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.
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The CMC Regulatory Landscape During Product Development, Manufacturing
Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services and strategic guidance.
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Simplify CAPA In 7 Steps9/20/2024
Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.
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5 Must-Haves For Electronic Batch Records In Life Sciences6/17/2025
Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.
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FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers10/9/2024
Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.
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The Problem With Construction Quality10/21/2024
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
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Unlock Robust And Reliable Stability Data With The Right Partner11/19/2025
Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.
REGULATORY COMPLIANCE SOLUTIONS
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The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.
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Boost lab productivity and throughput without sacrificing precision with a platform that helps teams work faster and smarter, all within a compact footprint that saves space.
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ÄKTA ready™ 450 system is a single-use liquid chromatography system.
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Accelerate Medical Writing Without Compromising Accuracy or Compliance
In the fast-paced world of clinical research, the ability to produce, review, and finalize high-quality documents—on time and with full regulatory compliance—is non-negotiable. Ideagen Document Review (formerly known as PleaseReview) is the trusted collaboration and co-authoring platform that enables clinical teams to streamline document reviews, reduce version chaos, and ensure traceable, auditable feedback across the board.
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Discover an enterprise asset management system for life sciences that combines maintenance, calibration, and compliance tools to boost productivity, reliability, and GMP readiness.