Regulatory Compliance Solutions

  1. Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements 4/14/2023

    As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

  2. Digital Batch Record 3/9/2026

    Explore a streamlined way to replace paper batch records with guided digital workflows that reduce errors, strengthen compliance, and improve visibility while providing a scalable path.

  3. 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.

  4. Optimize Your Contamination Control Strategy 10/21/2024

    An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.

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

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

  6. 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.

  7. X-Ray Inspection Solutions For The Pharmaceutical Industry 2/6/2025

    Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards.

  8. Comprehensive In-House Regulatory Compliance Solutions 1/14/2026

    Mikart’s pharmaceutical regulatory support team offers a full range of regulatory support, from completing your entire FDA e-submission to a la carte services customized to your project’s specific demands.

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

    Guide operators through dynamic workflows from equipment startup to maintenance.

  10. HyClone™ Cell Culture Media For Viral Vector Production 11/6/2025

    Whether you're looking to boost performance, enhance your capabilities, or simply get consistent, high-quality results, HyClone™ peak expression medium and HyClone™ prime expression medium are the solutions for you.