INSIGHTS ON REGULATORY COMPLIANCE
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![Businessman Using Tablet And Checklists GettyImages-1591153562]( "Reflecting Again On GMP Requirements For Marketing Authorization Holder")
Reflecting Again On GMP Requirements For Marketing Authorization HolderLearn in detail about Annex 16, the responsibilities of Marketing Authorization Holders (MAHs), and a practical way for MAHs to implement their responsibilities with their contract manufacturers.
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![Pharmaceutical manufacturing-GettyImages-806142222]( "What Drug Manufacturers Should Know About Operational Readiness")
What Drug Manufacturers Should Know About Operational ReadinessMoving 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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![rules, policies, regulatory documents-GettyImages-1438925546]( "Regulatory Compliance And Audits For Parenteral Manufacturing Precision")
Regulatory Compliance And Audits For Parenteral Manufacturing PrecisionCMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.
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![GettyImages-931182764 Cheerful Office Workers On Laptops]( "Unlocking Audit Success: Navigate Compliance With Confidence")
Unlocking Audit Success: Navigate Compliance With ConfidenceWatch expert Kathianne Ross explore ALCOA+ principles, audit preparation strategies, and the role of digital validation in enhancing compliance and audit success.
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Handling Protocols: Key Considerations In The Highly Potent API Market5/12/2025
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
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Developing Your Risk-Based Approach To Single-Use System Integrity10/29/2025
Explore how a holistic approach to single-use system integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing.
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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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5 Trends Impacting CMOs In 20252/4/2025
In 2025, CMOs will navigate Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.
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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.
REGULATORY COMPLIANCE SOLUTIONS
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![Pharma Manufacturing 450x300]( "Continuous Monitoring Of Cleanrooms And Isolators")
FMS/BioTrak/Portable/Remote/Environmental Sensors
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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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![CellGenix® Portfolio]( "High-Quality Raw Materials For Cell And Gene Therapy Manufacturing")
Explore growth factors and cytokines for regenerative medicine and cell and gene therapies offered in both GMP and preclinical grades.
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![GettyImages-2178732166-scientists-screen-imaging-microscope-laboratory]( "Application Guide For Multimode Readers")
Explore imaging, fluorescence, and luminescence-based techniques for cell analysis, viability, and gene expression, as well as how multimode readers streamline workflows and enhance data quality.
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![Genedata Bioprocess]( "Accelerate The Development Of Your Biotherapeutic Drugs")
Accelerate biotherapeutic development with a platform that integrates data across CLD, USP, DSP, and analytics, which supports advanced technologies, ensures compliance, and streamlines workflows.
