Featured Insights

1. Creating A Compliant And Scalable CGT Logistics Launch Plan 6/12/2025

   As cell and gene therapies advance to commercialization, biopharma companies face immense logistical hurdles. A customized, end-to-end strategy is crucial for ensuring product integrity and market success.

2. Essential Guide To Post-Approval Regulatory Lifecycle Maintenance 4/14/2025

   Learn about the growing trend of regulatory affairs outsourcing in pharma, driven by R&D growth and the need for specialized expertise to manage product lifecycles effectively.

3. The Advantages Of Pharmacovigilance Outsourcing At The Local Level 4/14/2025

   Outsourcing pharmacovigilance tasks can free up local teams for strategic work. Learn how to build effective partnerships by aligning needs, understanding capabilities, and fostering collaboration.

4. Early Network Mapping To Guide HTA Literature Reviews 3/18/2025

   How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.

5. Advanced Aseptic Filling Technology And Annex I Compliance 1/2/2025

   NIBRT's new isolator training facility in Dublin offers hands-on experience with advanced aseptic filling technology, addressing Annex 1 compliance and industry challenges in sterile drug manufacturing.

6. Best Practices In The Design Of A Pharmaceutical Manufacturing Facility 11/6/2024

   A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.