Webinar - Navigating IND Filings: Key Strategies for Early-Stage Drug Development Success

In the fast-paced world of pharmaceutical development, balancing the complexities of early-stage research, regulatory requirements, and compliance is critical for achieving successful Investigational New Drug (IND) submissions. Early-stage 'fit-for-purpose' development focuses on producing batches for GLP toxicology studies, ensuring initial GMP production, and addressing regulatory challenges, while supporting the pharmacology and pharmacokinetics of drug candidates.

This webinar offers expert insights into managing IND filings efficiently with real-world case studies. The presentation will touch on key aspects of early-stage development, such as generating the necessary pharmacological and toxicological data, while maintaining an emphasis on optimizing API and formulation R&D and production, impurity controls, and the overall regulatory submission process.

Join us as we explore practical steps to harmonize compliance, timelines, and costs, ensuring a smooth transition from preclinical development to successful IND filings and clinical trials.

Learn about our speaker

William LIAN

Director of Filing and Regulatory Affairs Office, BioDuro-Sundia