INSIGHTS ON REGULATORY COMPLIANCE
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Qualified Reference Standards: Setting The Standard For Product Quality
Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.
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Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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A Partner Who’s Continuous Flow Ready
Through the combination of process optimization, modularization and automation, our continuous flow process can improve the productivity and quality of pharmaceuticals by increasing process robustness, reducing chemical waste, and making it easier and safer to handle unstable chemicals.
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Identifying And Preventing Common Data Integrity Issues
Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate. A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.
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Insights Into The Medical Device Single Audit Program (MDSAP)4/19/2022
Learn how the The Medical Device Single Audit Program allows a single regulatory audit to satisfy the requirements of jurisdictions around the world.
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Annex 11: The EU’s New Expectations For Regulated Computerized Systems8/27/2021
The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.
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Apheresis Variability Control In Cell Therapy Manufacturing7/25/2022
Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.
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503B Sterile Compounding Facility Goes Paperless With QMS Software8/23/2021
As part of its continuous improvement program to drive additional growth and increase efficiencies, QuVa Pharma sought to optimize its testing processes — aligning lab operations and quality efforts to maximize resources and minimize paper-based processes. Read how using the Manufacturing Excellence™ solution in the laboratory has significantly improved process throughput, employee proficiency, cross-functional team collaboration and quality.
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Alcohols For Use As An Antimicrobial Agent12/1/2022
Care must be taken when determining the use of alcohols in any controlled environment. Learn about the many useful and practical properties of alcohols along with important regulations.
REGULATORY COMPLIANCE SOLUTIONS
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Learn how to transform your contract organization into a completely paperless, connected lab with our informatics solutions, which deliver robust, proven results and reduce regulatory risk.
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Our development expertise across all gene therapy modalities (AAV, lentivirus, oncolytic virus, etc.) and proven clinical through commercial scale-up capabilities will provide full life cycle support of your life-saving therapeutic.
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Our innovation platforms and customized solutions provide high-quality, advanced and biocompatible polymers to help our clients innovate new healthcare technologies, mitigate risk through regulatory compliance and create eco-responsible materials.
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As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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The Crystal Zenith (CZ) polymer addresses the need for a clear, biocompatible material that overcomes problems inherent in glass vials, syringes and cartridges.