Insights On Regulatory Compliance

1. How Recent Trends Impact Bringing Your Molecule To Market 7/9/2024

   With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

2. Why The Latest Technology Helps Navigate Evolving Regulator Expectations 11/27/2024

   By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.

3. Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights 3/5/2025

   Explore the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

4. The Importance Of Auditing CDMOs 11/26/2025

   Auditing CDMOs ensures compliance, mitigates risk, and strengthens partnerships by verifying quality systems, regulatory adherence, and communication, critical for safeguarding product integrity and patient safety.

5. Ensure Sterility In Small-Batch Drug Production 1/9/2026

   Automation and sterility are critical for small-batch drug manufacturing. Learn how robotic isolators streamline vial filling, reduce contamination risk, and support advanced therapies with precision.

6. Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance 6/6/2024

   Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

7. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

   When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

8. How CMOS/CDMOS Drive Industry Growth 4/16/2025

   From minimizing costs and accessing advanced tech to speeding market entry, dive into how outsourcing drug development and manufacturing to CMOs/CDMOs offers strategic advantages.

9. Mitigating Nitrosamine Risks In Pharmaceuticals 6/25/2024

   Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

10. 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.