Transactional Content Management
PRODUCTS
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There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.
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Digital services on a scale that is unique in the industry, including visual support with augmented reality, remote diagnosis via QR code, and visual spare parts search. The core is the myHERMA customer portal, in which the machine cockpit is also integrated - for a perfect overview of all ordered and installed devices.
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Biomanufacturers need a flexible and scalable approach to fluid handling to overcome complex regulatory demands and improve production efficiency. Fluid handling solutions from Avantor®, including agile single-use solutions and Masterflex® peristaltic pumps, enable biomanufacturers to bring breakthrough therapies to market quickly and safely.
Masterflex® peristaltic pump systems, engineered for a long life, provide superior accuracy and repeatability, ensuring optimal performance from the research phase to scaled-up production.
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The AMM-9619PSM is a compact surface-mount amplifier designed for applications requiring reliable performance across a wide frequency range.
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Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
WHITE PAPERS AND CASE STUDIES
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Increase Production Capacity With Virtualized Process Automation
Learn how Sleeman Breweries grew their production, improved process control, and avoided the high expense of building a new greenfield facility.
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Leveraging The Bolar Exemption To Accelerate Market Access
Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.
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Understanding Complexities Of Bioabsorbable Materials Achieves Consistent IV Loss
Expertise in bioabsorbable materials led to success in a major medical device challenge through a tailored approach, equipment, and proven protocols.
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Pharma Manufacturing: Top 10 Pitfalls To Avoid
Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?
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From Paper To Digital Study Management In Large Patient Registries
Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.
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Decentralized And Community-Based Solutions Driving Women's Healthcare
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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EMCCD vs sCMOS - Cameras For Confocal Microscopy
When is it then appropriate to use an EMCCD camera or an sCMOS camera as a detector for spinning disk confocal microscopy – the biologist’s technique of choice for fast, multi-dimensional live-cell imaging?
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Developing A Data Strategy For Clinical Trials
This white paper outlines a standardized method for developing a data strategy that can be tailored to a company's current needs and adapted as those needs evolve.
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A Synergy Of Excellence: Partnership During Unprecedented Times
Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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A Risk-Based Approach To Plasmid DNA And mRNA Process Development
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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Padre Dam Water District Finds Flushing Solution In WinCan
Learn about a program that utilizes technology to maximize efficiencies while maintaining reliable wastewater services in East San Diego County.
NEWS
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Pioneering 'Hybrid Chips' To Make The Most Advanced Square Centimeter Even More Efficient5/27/2024
TU/e is the ideal place to bring electronics and photonics together and accelerate the digitization of our modern lives.
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The Risk Of Global Water Scarcity Is Greater When Accounting For The Origin Of Rain9/2/2024
Securing the world's water supply is one of the greatest challenges of our time. Research at Stockholm University is now presenting an alternative method for quantifying the global risk of water scarcity.
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Breaking Carbon–Hydrogen Bonds To Make Complex Molecules11/8/2024
A team of scientists led by Caltech and Emory University has synthesized a highly complex natural molecule using a novel strategy that functionalizes normally nonreactive bonds, called carbon–hydrogen (C–H) bonds.
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Low-Noise Transducers To Bridge The Gap Between Microwave And Optical Qubits3/19/2025
In the effort to build superconducting quantum computers, researchers around the world are working to develop electrical circuits that operate in the microwave domain using individual particles of microwave radiation, or microwave photons, as qubits—the basic building blocks of quantum computing.
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Discovery Of Critical Iron-Transport Protein In Malaria Parasites Could Lead To Faster-Acting Medications10/28/2024
Malaria kills over 600,000 people a year, and as the climate warms, the potential range of the disease is growing. While some drugs can effectively prevent and treat malaria, resistance to those drugs is also on the rise.