Regulatory Compliance Solutions

  1. Small Is Powerful, Small Is Green

    As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.

  2. Pharmaceutical Asset Management & Reliability Services 12/21/2020

    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.

  3. Regulatory Services Offering 12/3/2023

    Navigating the path toward regulatory approval is a complex process. Learn how partnering with Societal™ CDMO and leveraging regulatory expertise can empower your organization to achieve its goals.

  4. Biopharma Manufacturing Process Data Made Simple 9/6/2023

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

  5. Pharmaceutical Operational Readiness Programs 10/24/2024

    Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.

  6. 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."

  7. 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.

  8. Psychedelics: Drug Development Capabilities 10/30/2023

    Learn how harnessing a CDMO’s extensive knowledge and skills in dealing with controlled substances can help you advance your innovative psychedelic therapeutic safely and efficiently.

  9. Continuous Monitoring Of Cleanrooms And Isolators 1/30/2020

    FMS/BioTrak/Portable/Remote/Environmental Sensors

  10. ERP Regulatory Compliance 4/28/2022

    The Kymanox Intelligent Enterprise Team is an international provider of ERP compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach balanced with both regulatory requirements and business needs.