INSIGHTS ON REGULATORY COMPLIANCE
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Harmonizing Regulatory Guidelines For Assay Validation
Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.
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Why Biopharma Breakthroughs Aren't Moving The Market
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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Environmental Microbial Monitoring In Advancing Automation
Watch how a single-use microbial impactor revolutionizes contamination control in robotic filling lines to enhance sterility, efficiency, and compliance in fully automated manufacturing environments.
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Are You Aligned With FDA's Computer Software Assurance Methodology?
Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.
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Normalized Data In Microbial Continuous Monitoring7/24/2025
Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.
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Why The Latest Technology Helps Navigate Evolving Regulator Expectations11/27/2024
By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.
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Implementing Rapid Microbial Identification In Biotherapy Manufacutring5/27/2025
Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.
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Client Story: Efficiency Enabling CSV At Scale7/1/2025
Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.
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Why Compounding Pharma Manufacturers Should Evaluate BFS Systems12/5/2024
Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.
REGULATORY COMPLIANCE SOLUTIONS
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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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Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.
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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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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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Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.