INSIGHTS ON REGULATORY COMPLIANCE
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Why The Latest Technology Helps Navigate Evolving Regulator Expectations
By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.
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Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter
Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.
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Improving Bioprocess Monitoring And Control With Multivariate Data Analysis
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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ICH Quality Risk Management Guidelines For Biopharma Manufacturing
Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.
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A Risk-Based Approach To Plasmid DNA And mRNA Process Development9/23/2025
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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ICH Q9 Revision 1: Enhancing Quality Risk Management8/12/2024
ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
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Getting Equipped For The Future With A New Microbial Air Sampler8/25/2025
Discover how a new microbial air sampler meets evolving production demands to enhance compliance, reduce errors, and streamline air monitoring in today’s digital, GMP-regulated environment.
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Virus Filtration: Regulations And Mechanisms7/25/2024
In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.
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Biopharma Supply, Reimagined: Blarney, A Climate-Neutral Facility For Best-In-Class Filters11/11/2025
Explore how a new, climate-neutral manufacturing facility strengthens biopharma supply chains. Understand the benefits of its advanced filtration technologies and commitment to environmental sustainability.
REGULATORY COMPLIANCE SOLUTIONS
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SoftMax® Pro Software - The most published microplate reader control and data analysis software
Preconfigured protocols and custom assay workflows simplify microplate data acquisition and analysis
SoftMax® Pro Software for Windows 10 is designed to provide the simplicity, flexibility and power required for advanced data analysis. It provides ready-to-run protocols, analysis algorithms, and 21 different curve fit options. Every step is optimized for data acquired from a Molecular Devices microplate reader or data imported from another source to simplify analysis and reporting. Compliance tools are available for regulated laboratories providing end-to-end chain of custody.
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Using Document Change Control Software in Regulated Environments
Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.
In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.
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As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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Explore how automated plate washers improve ELISA, bead-based, and cell-based assays with precision, flexibility, and reproducibility that is ideal for high-throughput labs seeking consistent results.
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Titanium dioxide is extensively used in solid dosage forms as an opacifier and colorant. Due to regulatory developments and restrictions by authorities, formulators are increasingly interested in titanium dioxide-free solutions for both dietary supplements and medicinal products. Uniform colored and white coatings applied to tablets not only have an aesthetic function but also improve patient compliance.