INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1386852216 cell therapy]( "Accelerated Development: Gene Therapy Vs. Small Molecule")
Accelerated Development: Gene Therapy Vs. Small MoleculeCombined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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![Aseptic Filling GettyImages-1087219366]( "Opportunities And Risks As Biosimilars Come Of Age")
Opportunities And Risks As Biosimilars Come Of AgeAs biosimilars mature, they promise expanded patient access and healthcare savings. Despite regulatory hurdles, collaboration and innovation will drive their future growth and impact.
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![AST- ASEPTiCell ScreenShot 16]( "Technology Transfer Strategies: Fill-Finish Automation And Robotics")
Technology Transfer Strategies: Fill-Finish Automation And RoboticsEstablishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. Learn about the role that capable fill-finish solutions play in this process.
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![GettyImages-1413600685-scientists-collaborate]( "Embracing And Implementing Computer Software Assurance Guidance")
Embracing And Implementing Computer Software Assurance GuidancePharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.
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Creating Accurate, Efficient, And Effective CDMO Project Proposals8/15/2023
To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.
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Key Takeaways Of Annex 1: What It Means For Your Cold Chain Management10/19/2023
What are the practical implications of the latest Annex 1 update, specifically for cold chain management?
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Deviation And Change Control In Pharmaceutical Manufacturing9/20/2024
Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.
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What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product8/11/2023
Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
REGULATORY COMPLIANCE SOLUTIONS
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![MultiWash+ Microplate Washer]( "MultiWash+ Microplate 96- And 384-Well Automated Washers")
Compact microplate washer with maximum flexibility in a minimum footprint
The MultiWash+™ Microplate Washer is an automated, compact, quiet, efficient washer with 20 different wash protocol options. The variations include adjustable speed and volume, adjustable aspiration speed and time, adjustable soak times, and three modes of shaking. Four wash/rinse bottles are included and configurable for both 96- and 384-well plates.
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![SteriSEQ™ Rapid Sterility Testing Kit]( "Sterility Testing For Cell Therapy Bioproduction Samples")
This useful tool helps to ensure quality and safety in cell therapy products through the use of a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species.
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![Intelligent Automation AI]( "Pharmaceutical Automation And Information Technology Services")
As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.
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![molecular-devices-softmax-pro-software-products-plate-readers-hero]( "Simplify Microplate Data Acquisition And Analysis With SoftMax Pro Software")
SoftMax® Pro Software - The most published microplate reader control and data analysis software
Preconfigured protocols and custom assay workflows simplify microplate data acquisition and analysis
SoftMax® Pro Software for Windows 10 is designed to provide the simplicity, flexibility and power required for advanced data analysis. It provides ready-to-run protocols, analysis algorithms, and 21 different curve fit options. Every step is optimized for data acquired from a Molecular Devices microplate reader or data imported from another source to simplify analysis and reporting. Compliance tools are available for regulated laboratories providing end-to-end chain of custody.
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![iStock-1002126898-graph-tablet-meeting-risks-planning]( "Ensuring Compliance, Improving Efficiency, And Accelerating Time To Market With QMS Software")
A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.
