Regulatory Compliance Solutions
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ERP Regulatory Compliance
4/28/2022
The Kymanox Intelligent Enterprise Team is an international provider of ERP compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach balanced with both regulatory requirements and business needs.
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SAP Regulatory Compliance
4/28/2022
The Kymanox Intelligent Enterprise Team is an international provider of ERP compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach balanced with both regulatory requirements and business needs.
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Technology Transfer
4/28/2022
At Kymanox, our branded Technology Transfer methodology combines technical project management, sound science and engineering, quality and regulatory expertise, and business acumen to ensure Right First Time execution. Our approach is heavily based on following CGxP documentation best practices and has been honed over a decade of proven past performance.
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Valor® Glass: The Future Of Glass Packaging Is Here
Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
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Fast, Compact Absorbance Microplate Reader For a Wide Range Of Assays
6/20/2023
Filterless readers provide consistent results with steady temperature regulation
The SpectraMax® ABS and ABS Plus absorbance microplate readers provide the flexibility, sensitivity, and convenience for a wide range of assays such as ELISAs, microbial growth, and protein quantitation. Both readers feature an 8-channel read head for fast reads and a subset feature, the temperature independent PathCheck sensor that automatically normalizes and ensures accurate absorbance values by detecting pipetting errors. Combined with a wide application base, industry-leading SoftMax® Pro Software and validation tools, these readers fit in every lab and every budget.
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Good Clinical Practice
4/28/2022
When implementing quality decisions and compliance solutions for your Good Clinical Practice (GCP) investigations, Kymanox draws on its extensive life science and translational medicine experience. We prioritize patient safety and utilize expert project management to ensure scope, schedule, budget, and risk are tracked and communicated throughout your clinical programs.
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MasterControl Change Controlâ„¢
3/20/2023
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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Increase Employee Retention And Compliance By Investing In Quality Training From Waters
7/14/2022
Learn how to utilize enabling technologies, including instruments, informatics, and chemistry/consumables with our budget-friendly educational services.
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Bioproduction Regulatory Consulting Capabilities
12/20/2022
Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.
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RegOps Services To Streamline Regulatory Submissions
5/28/2024
Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).