Regulatory Compliance Solutions

  1. Compliance Program For EU Annex 1 Container Closure Requirements

    Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.

  2. A Cloud-Based Quality And Compliance Solution 9/8/2025

    Empower smarter decisions by combining trusted Salesforce integration and AI-enhanced quality management to drive efficiency, scalability, and continuous improvement across your organization.

  3. Process Challenge Device (PCD®) Selection Guide 10/16/2025

    Explore how standardized PCDs improve sterilization reliability, reduce costs, and support regulatory compliance, as well as technology that offers more consistent EO sterilization validation.

  4. 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.

  5. Particle Loss Studies 12/15/2025

    Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.

  6. 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.

  7. Solutions For Injectables And Parenteral Formulations 8/27/2025

    Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.

  8. Sterility Testing For Cell Therapy Bioproduction Samples 6/20/2024

    This useful tool helps to ensure quality and safety in cell therapy products through the use of a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species.

  9. Proven Vial Containment That Scales From R&D To Commercial 2/20/2024

    Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.

  10. Quality Risk Management Software 10/23/2024

    In the ever-evolving landscape of life science manufacturing, risk management is paramount to ensuring product quality, compliance, and timely market delivery. Meet MasterControl's Quality Excellence — your gateway to comprehensive and efficient quality risk management.