INSIGHTS ON REGULATORY COMPLIANCE
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Optimizing Process Loads For VHP Decontamination
Explore how CAI helped a company rescue a failing CQV project and create more efficient Vapourized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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How To Improve CAPA Metrics
A CAPA management system can provide your company with the ability to recognize and correct risks. Learn how to ensure your CAPA management system benefits the manufacturing process.
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Mitigate Drug Shortage Risk With Improved Collaboration
Learn how to overcome the hurdles associated with traditional data management approaches, and discover the key to reducing the risk of drug shortages in pharmaceutical manufacturing.
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Vaccines: Cleaning Regulations For Production12/1/2022
Learn about the critical cleaning and disinfection steps as well as the associated regulations manufacturers follow in their facilities to ensure product safety and the highest standards of product quality.
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Global Advantage With Free Trade Zones In China7/14/2022
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
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Over The Hurdles: Taking Psychedelics From Schedule I To Pharmacy10/12/2023
Learn how a partner with experience in handling scheduled substances and navigating FDA and DEA regulation can help you advance toward clinical research and drug development with ease.
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Early Development Considerations For Late-Stage NCE Success – Part One12/8/2023
Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.
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2023 Life Sciences Quality Trends3/16/2023
Discover advanced software solutions that offer connected and coordinated processes with real-time insights and predictive analytics to help you keep pace with the trends in quality management.
REGULATORY COMPLIANCE SOLUTIONS
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Explore a line of cost-effective and flexible thermogravimetric analyzers that provides enhancements in every aspect of TGA technology and a new level of user experience.
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The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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All Alconox Inc. detergents are Class I Medical Devices and listed as FDA-registered detergents. The list of the detergents is found on the FDA website with FDA Registration number 2410887. Alconox Inc. is also proud to be ISO9001:2015 and ISO13485:2016 Certified.
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Our platform is simple yet comprehensive. It’s scalable and secure. It combines our proven digital process automation, unmatched quality data management, and analytics into a single, natively connected platform. One that gives you tools to make quality a priority throughout your organization.
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We can assist in the development of necessary validation documents, including test protocols, based on current industry thinking and alignment with global regulatory authority expectations.