INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-2181060355-laptop-hand-check-mark-digital-validation]( "The GxP Digital Maturity Model")
The GxP Digital Maturity ModelExplore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
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![GettyImages-1344379539-manufacturing-men-holding-tablet]( "Choosing The Right PCD Configuration For Reliable Sterility Assurance")
Choosing The Right PCD Configuration For Reliable Sterility AssuranceAccurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.
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![GettyImages-2167548080 manufacturing]( "Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation")
Why A Dynamic, Digital Defect Library Is Now A Regulatory ExpectationMaintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
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![GettyImages-1465073079-pills-coated]( "Modified Release Formulations: Extending Drug Commercial Lifecycle")
Modified Release Formulations: Extending Drug Commercial LifecycleA CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.
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Achieving Ophthalmic Production5/23/2024
A partner with state-of-the-art facilities can guarantee efficient and scalable production of ophthalmic solutions, drops, and ointments, and is critical as you navigate the complexities of ophthalmic production.
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Regulatory Compliance And Audits For Parenteral Manufacturing Precision6/30/2025
CMOs 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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Essential Insights Into Pharmaceutical Product Release, Part 1 Of 212/27/2024
Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.
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Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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Challenges Associated With Building New Isolator Technology3/26/2024
Paula Rizo, Germfree’s Mechanical Engineering Lead for Equipment, dives deeper into our collaboration with AST and how this isolator technology will transform the way pharmaceutical companies approach aseptic processing.
REGULATORY COMPLIANCE SOLUTIONS
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![Pharma Manufacturing GettyImages-1135140594]( "Pharmaceutical Operational Readiness Programs")
Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.
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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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![Genedata Expressionist]( "Data Processing Across Instruments, Teams, And Sites")
Streamline mass spectrometry workflows with automated, harmonized data processing that delivers faster, more consistent results. Discover how you can reduce costs and improve efficiency.
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![White Tablets-GettyImages-172969989]( "Enhanced Opacity With Ideal Particle Properties")
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.
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![Regulatory compliance Getty Images-1256156511]( "Quality, Compliance, And Regulatory Services For Life Sciences")
The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
