Regulatory

1. Key Considerations When Developing Your Combination Product 2/20/2024

   Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

2. 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.

3. 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.

4. The Impact Of Water Activity Testing On Tablets And Capsules

   Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.

5. 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.

6. Micro Leak Detection Of Syringes, Vials And Liquid Filled Packaging With The VeriPac 455 11/16/2021

   VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging. The VeriPac 455 inspection technology that can be incorporated into protocols at any point in the handling process as it is non-destructive, non-invasive and requires no sample preparation. 

7. Strategies For Startups — How To Structure Milestones For Successful Outcomes 5/3/2021

   Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

8. Annex 1 FAQs: How Are We Responding To Provide Confidence For Customers? 5/11/2026

   For procurement and quality teams evaluating packaging and delivery component suppliers, understanding how a partner responds to regulatory change matters as much as the quality of their products.

9. 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.

10. 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.