Blogs

  1. Navigating The CGT Supply Chain: Key Logistical Challenges And Solutions 7/16/2025

    Commercializing cell and gene therapies requires overcoming complex logistical hurdles. Customized strategies for temperature control, compliance, and end-to-end delivery are crucial to prevent supply chain issues.

  2. Advancing Drug Safety: The Synergy Of Regulatory Affairs And Pharmacovigilance 7/14/2025

    Explore how pharmacovigilance and regulatory affairs teams work together throughout a product's lifecycle to monitor risks and keep vital safety information updated.

  3. CDISC + TMF Europe Interchange 2025: 5 Key Takeaways 7/14/2025

    The CDISC + TMF Europe Interchange showcased critical insights for TMF professionals. Learn about essential collaboration, the impact of AI, and the continued drive for standardization in clinical trials.

  4. How Digital Twins And Hybrid Modelling Optimize Cell Culture Process For Better Production 7/14/2025

    Discover how digital twins are enabling the optimization of cell culture processes for improved, more predictable outcomes in the creation of therapeutic proteins and antibodies.

  5. The New Language Of E6 R3: What Makes The Guidelines So Different? 7/14/2025

    Unpack the significant changes in ICH E6 (R3), nearly a decade after its last update. This revision brings renewed focus to quality by design and digital provenance.

  6. FDA Expands Unannounced Foreign Manufacturing Inspections 7/9/2025

    Unannounced FDA inspections are now the norm for foreign manufacturers. Learn how this pivotal shift impacts global drug, biologic, and device companies and how to prepare.

  7. Key Takeaways From The PDA Ireland Good Distribution Practice Event 7/9/2025

    Gain valuable takeaways from the PDA Ireland GDP event, covering essential insights on supply chain challenges, regulatory expectations, and the role of future technologies in pharmaceutical distribution.

  8. Advancing Sterile Manufacturing: A Strategic Imperative For Modern Pharmaceutical Production 7/9/2025

    Ensuring sterile drug production is vital for patient health and a key regulatory focus. Discover core principles and emerging trends in sterile manufacturing.

  9. HTA In Japan: The Glass Remains Half Full (For Now) 6/12/2025

    While Japan's current HTA system is seen as pro-innovation, potential reforms in 2026 could expand its scope, creating uncertainty for manufacturers in one of the world's largest markets.

  10. Early Access Program In France: How Much Of An Opportunity Is It? 6/12/2025

    Navigating France’s Early Access Program is more complex than ever. Amid declining approval rates and mandatory data collection, here’s what pharmaceutical companies need to know about the changing landscape.