Regulatory Compliance Solutions
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Regulatory Affairs Support Around The Globe
3/18/2025
With a dedicated advisor supporting you from development through submission and commercialization, you’ll benefit from our proven track record in securing approvals across a wide range of modalities.
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Commissioning, Qualification, Regulatory Compliance Services
4/27/2022
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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Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs
4/28/2021
Review our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.
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Software To Automate And Digitalize Data Recording Steps In QC Workflows
5/2/2023
Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.
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Low Endotoxin Products For Critical Environments
11/16/2022
Many Contec wipes and mops were developed through customer requests. Explore our wipes and mops along with how we minimize the risk of endotoxin contamination of a pharmaceutical product.
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A QMS Software That Enhances Operational Excellence
3/24/2025
Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.
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Cleanrooms And Equipment For Viral Vector Drug Manufacturing
6/9/2023
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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Optima™ XPN Ultracentrifuge
6/16/2023
1,500 mL max rotor capacity 100,000 max RPM 802,400 x g
Security and tracking Remote monitoring and control eXPert simulation software.
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Batch Execution Module
3/7/2025
Ecolab’s Batch Execution Module enhances pharmaceutical manufacturing with AI-driven scheduling, real-time monitoring, automated compliance checks, and proactive alerts to improve efficiency, quality, and regulatory adherence.
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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.