Regulatory Compliance Solutions

  1. Pharmaceutical Automation And Information Technology Services 12/21/2020

    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.

  2. Pharmacovigilance 5/28/2024

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

  3. Manufacturing Science & Technology (MS&T) And Supply Chain 4/27/2022

    At Kymanox, the Manufacturing Science & Technology (MS&T) and Supply Chain team, with its global experience in the biopharmaceutical and medical device industries, provides support for all product development phases from early clinical to post-commercial life cycle management.

  4. Analytical Sciences 4/27/2022

    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.

  5. Capture, Transmit, And Produce More Ions With The Triple Quad 6500+ System 6/19/2023

    Revolutionary sensitivity, speed, and performance with IonDrive technology

    The Triple Quad 6500+ system features multi-component IonDrive technology including the IonDrive High Energy Detector+ that pushes the boundaries of LC-MS/MS quantification farther than ever before. The revolutionary sensitivity, speed, and performance delivered through these technology enhancements enable you to see it all, from low mass to high mass compounds, in positive or negative polarity – in a single injection, with high sensitivity, reliability, and confidence.

  6. Cleanrooms And Equipment For 503B Outsourcing Facilities 6/9/2023

    Germfree understands the unique challenges associated with 503B sterile drug compounding

    Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.

  7. Global Experts In Nanotechnology And Drug Particle Engineering 3/9/2023

    Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  8. The Future Of Glass Packaging Is Here

    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.

  9. eCTD Submissions And Registrations Software 8/31/2021

    MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.

  10. As Biopharma Advances, So Must Our Data Integrity 10/4/2024

    Therapies are more complex, tailored, and varied than ever, and the associated amount of data is growing – which requires a new level of attention to detail.