INSIGHTS ON QUALITY ASSURANCE
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Regulatory Considerations Including Extractables & Leachables For Single-Use Manufacturing
Watch to gain insights into regulatory guidance for single-use manufacturing and risk assessment strategies for single-use implementation.
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Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
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Navigating The Regulatory Space To Biosimilar Approval
The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.
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Validation Of A Sterilization Process: Part 2
Gain essential insights into sterilization processes by exploring the Overkill method—an approach that ensures product safety through rigorous cycle development and validation.
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Human Performance In Pharma: Strengthening The Biotech Workforce11/24/2025
Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.
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MG America Virtual Pharma Expo September 2025: Oral Solid Dose Manufacturing And Packaging9/18/2025
Learn how to select the right containment solutions, explore technologies for encapsulated manufacturing, and identify critical phases in containment projects to protect operators and the environment.
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Cambrex Scientist Spotlight: Elena Bejan1/29/2025
Holding a Ph.D. in organic chemistry from Paris-Sud University and an MBA from the Rotman School of Management, Bejan leads R&D efforts at Cambrex with a focus on scientific innovation.
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3 Reasons Why Manufacturers And CDMOs Are Integrating QA, QC, And Manufacturing11/5/2025
Life sciences manufacturers are integrating QA, QC, and production to boost efficiency, reduce downtime, and scale smartly. Discover how Industry 4.0 technologies are reshaping operations.
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Accelerate Innovation With Compliant Software Solutions9/2/2025
Accelerate your innovation with software solutions that are designed to streamline operations, reduce costs, and speed time-to-market while ensuring compliance and data integrity.
QUALITY ASSURANCE SOLUTIONS
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We offer a broad range of manufacturing services and capabilities to produce high-quality devices including pen-injectors, auto-injectors, and wearables.
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Our platform is simple yet comprehensive. It’s scalable and secure. It combines our proven digital process automation, unmatched quality data management, and analytics into a single, natively connected platform. One that gives you tools to make quality a priority throughout your organization.
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Our experts implement proven, streamlined processes that maintain compliance, quality standards, and efficiency while also managing costs, schedules, and scope.
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Proof of concept studies with a proven path to manufacturing success.
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Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.