Regulatory Compliance Solutions

  1. 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.

  2. Quality Management And Compliance Consulting 4/29/2024

    Explore an extensive range of GxP services spanning CQV, Technical Consulting & Training, Quality Systems & Compliance, and Auditing for seamless project delivery and strategic support.

  3. Corrective Action Preventive Action (CAPA) Software For Life Sciences 8/23/2021

    Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

  4. MasterControl Change Control™ 3/20/2023

    Explore a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They're designed to allow “continuous validation” for FDA-regulated companies.

  5. Cleanrooms And Equipment For Viral Vector Drug Manufacturing 6/9/2023

    Viral vector manufacturing: key to successful gene therapy

    Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.

  6. Services Designed To Take You From Molecule To Market 6/12/2025

    Accelerate your biopharma journey with a comprehensive service portfolio designed to speed development, reduce costs, and minimize risk from molecule to market.

  7. Metrology Teams Collaborating With Waters 7/14/2022

    Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.

  8. Cell Therapy From Culture To Cure: Enabling Your Path From Discovery To Commercialization 6/10/2025

    Realize the full potential of your cell therapy research. Experience end-to-end support to overcome developmental complexities, helping you to efficiently and safely commercialize your groundbreaking treatments.

  9. GxP Compliance Solutions For GMP/GLP Labs 3/31/2025

    Advanced microplate detection systems and software help ensure top data integrity for your processes. Discover solutions and support that can enhance precision and compliance in your research and assays.

  10. Minimize Risk With Interactive Logbooks 8/19/2025

    Guide operators through dynamic workflows from equipment startup to maintenance.