01.29.25 -- Audit Readiness For Cell & Gene Therapy Companies

Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.

Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.

Learn about the three cleaning best practices that will make a difference in your cleanroom, the importance of each step, and how to implement these strategies.

Though conducting your clinical trial in Australia may initially seem daunting, the benefits are ample. Australia is home to qualified CRO partners that will guide your CGT to regulatory success.

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

Get a recap of what industry experts had to say about single-arm oncology registrational studies, success stories, and valuable lessons learned.

While organizations adapt to evolving safety and efficacy standards for mRNA, collaboration remains essential for navigating challenges like differing regional requirements, higher dosing needs, and analytical complexities.

Explore the power of MMS in identifying RNA base signatures. This study analyzes vibrational modes of A, G, C, and U, revealing insights into electronic environments and molecular interactions.