Regulatory

  1. 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.

  2. Human Factors Testing: Engaging End-Users In Med Device Development 3/11/2025

    Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

  3. 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.

  4. Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here? 5/3/2021

    There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field to accelerate life-saving therapies from the bench to the bedside.

  5. Nitrosamine Impurities Deadline: Are Your Products Compliant? 12/5/2023

    Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.

  6. 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.

  7. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  8. An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data 5/2/2023

    Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.

  9. EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

    Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.