January 19, 2026

Discover how the FDA's new guidelines for biosimilar development eliminate the need for clinical efficacy studies, emphasizing bioanalytical, pharmacokinetic, and immunogenicity data. Learn how to adapt your strategy and leverage high-quality analytics to achieve successful submissions and fast-track development.

January 19, 2026

Learn why early AAV potency assay development is key to smooth tech transfer, regulatory success, and phase-appropriate CMC strategies in gene therapy.

February 7, 2025

Discover the 4 pillars of a robust Pharmaceutical Quality System (PQS) that ensures drug quality and regulatory compliance. Learn how implementing quality-driven processes, maintaining a clean and safe environment, fostering communication and transparency, and ensuring consistent quality across platforms help meet Health Canada and U.S. FDA standards for drug development.