INSIGHTS ON REGULATORY COMPLIANCE
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High-Velocity Development: Gene Therapy Vs. Small Molecule
Combined 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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How Modern EQMS Solutions Are Powering Pharma’s Digital Revolution
If your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, learn why now is the time to start.
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Lessons Learned From Implementing FDA CSA Guidance
Explore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.
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MAM Solutions For Process, Product Control Of Biotherapeutic Proteins
With industry-leading scientific expertise and customer support, we have pioneered solutions to some of the most pressing challenges facing customers interested in adopting MAM into their organizations.
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ICH Quality Risk Management Guidelines For Biopharma Manufacturing11/27/2023
Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.
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Optimizing Process Loads For VHP Decontamination2/20/2024
Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.
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Do You Have an FDA Audit Process in Place?2/23/2023
Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.
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The Container Closure Integrity Requirements In The Revised EU Annex 111/21/2022
Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.
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Societal™ CDMO Capacity Update June 2023: Small Molecule6/21/2023
Societal is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
REGULATORY COMPLIANCE SOLUTIONS
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Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
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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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As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.
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Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.