Regulatory

  1. Annex 1 FAQs: How Do You Understand Risk Regarding Contamination Control? 5/11/2026

    True Annex 1 compliance requires a facility-wide contamination-control culture. Discover how rigorous risk awareness shapes behavior at every touchpoint across a manufacturing environment.

  2. Streamline Global Regulatory Submissions 5/21/2026

    Discover a more streamlined approach with one accountable partner supporting regulatory submissions globally.

  3. Selecting Container Closure Components: Extractables And Leachables

    Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.

  4. Annex 1 FAQs: Responding To The 2022 Revision 5/11/2026

    Viewing the Annex 1 revision as a natural extension of current habits, rather than a burden, allowed for a seamless transition. Since contamination control was already standard, the update simply validated existing excellence.

  5. Attracting The Right Capital — Forming Partnerships For Long-Term Success 5/3/2021

    Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

  6. Planning For Scale-Up 5/21/2026

    From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.

  7. Managing Risks In Injectable Drug Delivery 3/13/2025

    Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.

  8. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

    Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

  9. 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.

  10. Annex 1 FAQs: How Are We Responding To Foster Trust With Customers? 5/11/2026

    When regulations evolve, your suppliers’ ability to adapt shapes your ability to deliver. Learn how stronger manufacturing, quality, and personnel standards combined with radical transparency make compliance an advantage.