INSIGHTS ON REGULATORY COMPLIANCE
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![Operator loading nested vials into Microcell vial filler]( "CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics")
CDMO Uses Robotic Gloveless Isolator For Advanced TherapeuticsCDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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![GettyImages-2024513353 drug manufacturing]( "Achieving The Three Pillars In Life Science Manufacturing Validation")
Achieving The Three Pillars In Life Science Manufacturing ValidationIQ, OQ, and PQ validations ensure equipment reliability, compliance, and quality in medical device and pharmaceutical manufacturing, meeting regulatory standards.
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![Scientists working in lab-GettyImages-542935478]( "Cell Culture Media Mixing In A Benchtop Single-Use Mixer")
Cell Culture Media Mixing In A Benchtop Single-Use MixerExplore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.
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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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Success Story: Increased Productivity With Concentrated Fed-Batch6/30/2025
Discover how a leading biopharma company boosted flexibility and quadrupled productivity by implementing a concentrated fed-batch process in a single-use facility.
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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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Shaping The Future Of Process Intensification With Digital Solutions10/3/2025
Discover how automation, analytics, and AI are driving smarter process intensification and enabling a shift toward connected, continuous manufacturing.
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Combination Products: Navigating Regulatory Strategy, Design Verification5/19/2025
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
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SAP S4HANA Implementation: Commissioning, Qualification, And Validation2/20/2024
Explore how CAI helped one company navigate complications when implementing SAP and how new solutions are being developed, validated, and implemented to establish this new global ERP system.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1180547354 digital data]( "MasterControl Change Control™")
Explore a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They're designed to allow “continuous validation” for FDA-regulated companies.
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![ViralVectors]( "Cleanrooms And Equipment For Viral Vector Drug Manufacturing")
Viral vector manufacturing: key to successful gene therapy
Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.
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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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![GettyImages-1388184871-quality-compliance-approval]( "A First-Of-Its-Kind Advanced Qualification Dossier")
This unique and comprehensive “On-Demand” dossier is designed to address the qualification requirements and provide all the information needed for your specific assembly in one location.
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![Phenomenex Zebron]( "Columns To Optimize Your GC Analysis")
Optimize Your GC Analysis with Zebron GC Columns
Zebron GC columns are engineered with quality of analysis in mind to better support scientists' research and regulatory analysis for environmental, food safety, food quality, forensics, pharma, fuels, and specialty chemicals.
