Regulatory

  1. Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1? 5/11/2026

    EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.

  2. Ensuring Integrity: A Comprehensive Approach To CCI 1/8/2026

    Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.

  3. Navigating GxP Compliance Challenges 10/30/2024

    Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

  4. Start Packaging Development Early 5/12/2026

    To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.

  5. Your Contract Manufacturer Partner 12/14/2020

    Discover an integrated solution for pharmaceutical companies that offers a broad range of manufacturing services and capabilities to produce high-quality devices.

  6. Annex 1 FAQs: Why Is A Good Supplier Partnership Pivotal To Meet Regulatory Expectations? 5/11/2026

    Struggling to keep pace with EU GMP Annex 1? The right supplier partnership brings critical regulatory insight your team may be missing. Learn how strategic collaboration closes compliance gaps and prepares you for future regulations.

  7. Package Integrity Testing Of Dry-Fill Flexible Packaging With VeriPac FLEX 11/16/2021

    The VeriPac FLEX Systems are available in several configurations to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics.

  8. Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability 11/21/2022

    Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.

  9. Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1? 5/11/2026

    Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.

  10. Simplifying Bioprocess Data Collection 2/17/2023

    Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.