This podcast examines the critical role of Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical drug development process, particularly for early-stage startups aiming for Investigational New Drug (IND) applications. It highlights how many new companies underestimate the complexity and importance of early CMC planning, leading to common pitfalls such as inadequate characterization, suboptimal manufacturing processes, and neglecting quality systems. The text then introduces Molgenium and its founder, Dr. Mohamad Toutounji, as a professional resource offering expert solutions in GMP, CMC, and regulatory affairs to help startups navigate these challenges effectively and accelerate their path to clinical trials.