Regulatory Compliance Solutions

  1. Rapid Sterility Testing: Actionable Results In Less Than 5 Hours 6/20/2024

    Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.

  2. SCIEX M5 MicroLC System 9/6/2023

    See More with Microflow LC-MS

    The M5 MicroLC system is the perfect balance of sensitivity and robustness—more sensitive than traditional analytical flow LC, and more flexible and more robust than nanoflow LC — giving you the potential to optimize your critical workflows, today and into the future.

  3. Strategic Regulatory Documentation Practice 5/31/2023

    Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.

  4. A QMS Software That Enhances Operational Excellence 3/24/2025

    Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.

  5. Analytical Method Validation 4/28/2022

    Kymanox supports pharmaceutical, biotechnology, medical device, and in vitro diagnostic device manufacturers in the validation of methods according to regulatory guidelines. We ensure phase-appropriate validation characteristics are clear for the intended application.

  6. Fast, Compact Absorbance Microplate Reader For a Wide Range Of Assays 6/20/2023

    Filterless readers provide consistent results with steady temperature regulation

    The SpectraMax® ABS and ABS Plus absorbance microplate readers provide the flexibility, sensitivity, and convenience for a wide range of assays such as ELISAs, microbial growth, and protein quantitation. Both readers feature an 8-channel read head for fast reads and a subset feature, the temperature independent PathCheck sensor that automatically normalizes and ensures accurate absorbance values by detecting pipetting errors. Combined with a wide application base, industry-leading SoftMax® Pro Software and validation tools, these readers fit in every lab and every budget.

  7. Sterility Testing For A Connected Era 5/7/2024

    This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.

  8. Bioproduction Regulatory Consulting Capabilities 12/20/2022

    Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.

  9. Validation (CQV) 4/27/2022

    Kymanox caters to your specific needs to get CGxP Commissioning, Qualification, and Validation (CQV) done. Key practice areas are all-encompassing and include process, cleaning, analytical methods, facilities, clean utilities, equipment, methods, computer systems, and environmental chambers.

  10. Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs 4/28/2021

    Review our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.