INSIGHTS ON REGULATORY COMPLIANCE
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![Laboratory-analysis-GettyImages-1385463753]( "Tips For Viral Vector Production")
Tips For Viral Vector ProductionLearn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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![Compliance GettyImages-1212446127]( "Why Perform A D-Value Study? Reference Review")
Why Perform A D-Value Study? Reference ReviewUnderstanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.
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![GettyImages-2181247946-business-people-office-documents-pen]( "Why Biotech Leaders Can't Afford Delays In Document Review")
Why Biotech Leaders Can't Afford Delays In Document ReviewDocument review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.
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![West]( "FAQs On The Revised EU GMP Annex 1: Volume 3")
FAQs On The Revised EU GMP Annex 1: Volume 3The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
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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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GMP Calibration Management8/8/2025
Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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What Drug Manufacturers Should Know About Operational Readiness6/4/2025
Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.
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Harmonizing Regulatory Guidelines For Assay Validation7/24/2024
Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.
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Takeda's Global Validation Transformation9/9/2025
Discover how Takeda transformed its validation process by replacing paper-based workflows with a digital solution to boost efficiency, compliance, and data integrity.
REGULATORY COMPLIANCE SOLUTIONS
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![Thermo Testing System]( "Rapid Sterility Testing: Actionable Results In Less Than 5 Hours")
Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.
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![Fluent® Laboratory Automation Workstation For Compound Management]( "Streamline Your Workflow With Impressive Speed And Flexibility")
Accelerate compound management with precision pipetting, smart automation, and scalable throughput with an intuitive software that simplifies complex workflows while enhancing traceability and compliance.
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![phenomenex securitylink]( "SecurityLink™ HPLC/UHPLC Fingertight Fittings")
The SecurityLINK fingertight fitting system simplifies your system and column connections and provides consistent performance with torque limiting technology that prevents column damaging overtightening.
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![molecular-devices-softmax-pro-software-products-plate-readers-hero]( "Simplify Microplate Data Acquisition And Analysis With SoftMax Pro Software")
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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![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
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.
