INSIGHTS ON REGULATORY COMPLIANCE
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Aseptic Expertise And Delivery Of Services
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Practical Solutions For Protein Analytics And Residual DNA Testing
Discover practical solutions for common quality control bottlenecks in biotherapy manufacturing. Learn how to improve protein analytics and DNA testing robustness and accelerate time to market.
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Faster, Smarter Quality Decisions: Powered By TSI FMS Web Client Charts
Quickly visualize and access manufacturing data over time with customizable graphs. Prioritize critical information for faster, smarter quality decisions.
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Compound Library Consortium
Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.
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Data-Driven Methods for Ensuring Container Closure Integrity12/18/2024
An integral component to a robust quality control program is container closure integrity testing (CCIT), which helps ensure the prevention of contamination and/or the degradation of a product.
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Understanding cGMPs For Phase 1 Investigational Drugs8/15/2025
Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny?7/25/2025
Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.
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Simplifying Final Filling - Single-Use Transfer And Filling Solutions8/7/2025
Explore a single-use system for secure final filling and aseptic transfer that is designed to boost productivity, minimize contamination, and maximize product recovery.
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Reduce Batch Failure Risk With An Innovative Platform6/11/2025
Enhance reliability in cell therapy manufacturing with an innovative platform. Discover how the closed system and automation reduce operator errors through smart monitoring, pre-checks, alarms, and detailed batch reporting.
REGULATORY COMPLIANCE SOLUTIONS
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Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.
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The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).
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Configurable readers with triple-mode cuvette ports, validation tools, and compliance software.
The SpectraMax® M Series Multi-Mode Microplate Readers measure UV and visible absorbance, fluorescence, luminescence, fluorescence polarization, TRF and HTRF.
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Explore cycle development and validation services and biological indicator testing services from an ISO-certified laboratory, registered with the FDA and DEA.
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Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.