The investigational new drug (IND) application marks a pivotal moment in your drug’s journey. As per the Food and Drug Administration (FDA) guidelines, an IND submission necessitates comprehensive elements, including animal pharmacology studies, toxicology studies, manufacturing details, clinical protocols, and investigator information.
At Aragen, we offer comprehensive CMC (Chemistry, Manufacturing, and Controls) support for your IND application from process chemistry and drug substance manufacturing to formulation development and manufacturing. Throughout this journey, our analytical team conducts rigorous quality analysis to ensure that your program meets its milestones. With collaborative efforts from process chemistry, drug product, and analytical experts working together, we maximize the potential success of your molecule.
