INSIGHTS ON REGULATORY COMPLIANCE
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![nitrosamines_milliporesigma]( "Nitrosamines - New Requirements To Evaluate Contamination Risks")
Nitrosamines - New Requirements To Evaluate Contamination RisksExplore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.
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![GettyImages-1469145905-key-unlock-key-hole-door]( "Three Key Strategies To Guide Efficient And Effective Recall Management")
Three Key Strategies To Guide Efficient And Effective Recall ManagementDiscover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.
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![anticancer drug, ADC-GettyImages-2148345960]( "Improving Productivity And Purity In ADC Polishing")
Improving Productivity And Purity In ADC PolishingDiscover how a CDMO achieved 40x productivity and 15% cost savings by switching to rapid cycling membrane chromatography for ADC polishing, which helped cut process time and buffer use.
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![05 West]( "Leachables Method Development, Validation And Relevant ICH References")
Leachables Method Development, Validation And Relevant ICH ReferencesIt is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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Digitalizing Pharma Control Strategies: A Roadmap1/24/2025
Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.
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5 Drug Manufacturing Trends To Look For In 20251/6/2025
The life sciences industry faces big changes in 2025. Companies must adapt to new regulations, AI, and shifting manufacturing landscapes to stay competitive and drive innovation.
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Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing6/13/2025
Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
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Why The Latest E2500-25 Standard Revision Demands Immediate Action9/14/2025
The updated E2500-25 standard transforms pharmaceutical manufacturing with a proactive, risk-based approach, enhancing compliance and accelerating the delivery of therapies to patients.
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Dry Powder Media Manufacturing Grand Island Expansion11/5/2025
Take a video tour of our newly expanded dry powder media manufacturing facility in Grand Island, New York. The expansion has added more than 45,000 square feet of Animal Origin Free (AOF) manufacturing space to help meet increasing global demand.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1370928101 regulatory compliance]( "Regulatory Affairs: Meeting The Highest Standards")
With a dedicated advisor supporting you from development through submission and commercialization, you’ll benefit from our proven track record in securing approvals across a wide range of modalities.
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Culture Media For Biological Indicators")
Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
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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.
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![Pharma bioprocess quality GettyImages-1138461306]( "Metrology Teams Collaborating With Waters")
Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.
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![csm_RImanager_-_Analyser_16-9_c468a9372a]( "Regulatory Information Management Software For Manufacturing")
RImanager centralizes regulatory and product data, integrates with production, and streamlines planning, tracking, and approvals to bring new drugs to market faster and reliably.
