INSIGHTS ON REGULATORY COMPLIANCE
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Navigating GxP Compliance Challenges
Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.
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Single-Use Strategies For Uninterrupted Microbial Monitoring
Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.
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The GxP AI Podcast: Unveiling the AI Model Validation Cheat Sheet
Discover how AI is revolutionizing biotech manufacturing as Toni and Christian reveal the story, strategy, and regulatory impact behind their innovative AI model validation cheat sheet.
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Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.
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Leachables Method Development, Validation And Relevant ICH References5/16/2025
It 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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Project Management: The Secret Weapon In Effective Tech Transfer5/23/2024
Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.
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The Future Of GxP Manufacturing With AI4/21/2025
Discover 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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A Robust Extractables Data Package Helps Drive Patient Safety10/1/2024
Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.
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Top 3 Mistakes Companies Make During Sterilization Validation5/27/2025
Sterilization validation is essential for product safety and compliance. Discover the top three mistakes companies make and learn practical strategies to avoid delays, non-compliance, and patient safety risks.
REGULATORY COMPLIANCE SOLUTIONS
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From safety considerations to kid-friendly dosing, we can help you get your pediatric formulation right.
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Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.
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AST’s aseptic processing solutions are outfitted with the latest in intuitive cGMP technology designed to optimize the fill-finish process for the highest standards of quality and regulatory compliance.
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Enhance your chromatographic performance with advanced HPS technology to improve analyte recovery, peak shape, and reproducibility for complex compounds and demanding analytical workflows.
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Learn about fast, reliable ELISA readings with LED optics, robust data analysis, and automation-ready design that is validated for IVDR and FDA compliance to support efficient lab operations.