INSIGHTS ON REGULATORY COMPLIANCE
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![Bucket Purity kit]( "High-Resolution Characterization Of Both sgRNA And Cas9 mRNA")
High-Resolution Characterization Of Both sgRNA And Cas9 mRNAImprove your characterization of both RNA integrity in the final product and RNA fragmentation with an analytical kit-based solution.
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![Compliance GettyImages-1212446127]( "Why Perform A D-Value Study? Reference Review")
Why Perform A D-Value Study? Reference ReviewUnderstanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.
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![Germfree guide passthrough]( "Guidance For Pass-Throughs In cGMP Cell And Gene Therapy Facilities")
Guidance For Pass-Throughs In cGMP Cell And Gene Therapy FacilitiesHow do active purging pass-throughs offer a higher level of material control for cell and gene therapy facilities?
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![Little Patients, Big Challenges: Developing Pediatric Formulations Splash]( "Little Patients, Big Challenges: Developing Pediatric Formulations")
Little Patients, Big Challenges: Developing Pediatric FormulationsExplore the development of high-quality, child-friendly oral formulations, as well as learn about new testing requirements for impurities and innovative approaches to creating age-appropriate medications.
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Sustainable Solutions For Medical Devices1/6/2025
Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.
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When Should Filter Validation Be Performed?8/21/2024
Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.
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How Generative AI Streamlines GxP Compliance In Life Sciences9/20/2024
Generative AI is reaching a critical juncture in the life sciences industry. Learn how it is changing the game for GxP Compliance and enabling organizations to improve operational efficiency.
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Catalent's Journey Of Continuous Improvement For CSV Excellence3/19/2025
Discover how organizations like Catalent must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.
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Overview Of Biological Indicator And Sterilization Monitoring Systems7/2/2024
Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.
REGULATORY COMPLIANCE SOLUTIONS
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At Kymanox, we have extensive experience eliminating complaint backlogs and identifying appropriate corrective actions. We work to proactively identify roadblocks and bottlenecks that slow down progress. We collaborate with your Device, Pharma, Quality, and Manufacturing teams to ensure investigations are thorough and accurate by identifying patterns and trends to streamline the investigation process.
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The Kymanox Analytical Sciences group has professionals with global experience in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide ongoing support for all phases of development, from discovery to post-commercialization. With a comprehensive library of proven templates covering study design through final reporting, we meet required timelines and maximize effectiveness and efficiency.
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![CAI logo 2024]( "Pharmaceutical Asset Management & Reliability Services")
Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.
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![Ecolab - cleanroom]( "Optimize Your Contamination Control Strategy")
An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.
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![Regulatory compliance Getty Images-1256156511]( "Quality, Compliance, And Regulatory Services For Life Sciences")
The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
