INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1788431592-patent-application-desk-glasses-pen-paper]( "The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly")
The Patent Cliff Looms – Design Your Biosimilar Approach AccordinglyIn your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.
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![eurofins facility cleaning]( "Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny?")
Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny?Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.
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![GettyImages-2166459777 digital twins, technology]( "Digitalizing Pharma Control Strategies: A Roadmap")
Digitalizing Pharma Control Strategies: A RoadmapDigitalizing 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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![Cell and Gene Tech Expo]( "The Future Of GxP Manufacturing With AI")
The Future Of GxP Manufacturing With AIDiscover how to digitize batch records in just 180 days with Christian Gay Porcel by leveraging AI for automated compliance and scalable validation.
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Achieve Pharma 4.0 With Next Generation Software-Defined Manufacturing11/5/2025
Explore how software-defined manufacturing is helping companies overcome legacy system challenges, improve OEE by up to 25%, and accelerate batch release cycles while maintaining compliance.
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Navigating The FDA's Drug Supply Chain Security Act3/14/2025
Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
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Overcoming Excipient Risks And Challenges For Parenteral Formulations8/27/2025
Excipients are essential to parenteral formulations, which help protect APIs, enhance stability, and ensure safety. Learn how strategic excipient selection can optimize drug performance and patient outcomes.
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The Evolution Of EAM/CMMS In Pharma Manufacturing8/8/2025
Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.
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PUPSIT As Part Of A Contamination Control Strategy (CCS)8/21/2024
Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.
REGULATORY COMPLIANCE SOLUTIONS
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![Doctor-Comforting-Patient-GettyImages-157718473]( "Clinical Pharmacology Services")
With over 30 years of proven experience, we provide comprehensive clinical pharmacology services, from data management and analysis to the generation of clinical study reports.
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![Compliance GettyImages-1212446127]( "Commissioning, Qualification, Regulatory Compliance Services")
We help you implement innovative approaches that help you achieve higher quality, increased reliability, faster project delivery, reduced energy and operating costs, and an integrated, business focused approach to regulatory compliance.
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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Next-Generation Genotyping Made Simple")
Discover a fast, scalable SNP genotyping solution that combines high accuracy, low input requirements, and reduced sequencing costs, which are ideal for large-scale studies across diverse organisms.
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![GettyImages-139602926 labeling, packaging, pharma]( "Packaging Software: OEE, EBR, Track And Trace")
Werum PAS-X Packaging optimizes efficiency, compliance, and transparency in your packaging line, combining OEE monitoring, electronic batch recording, and track & trace in a single scalable system.
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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.
