Purchase of Formulation development and GMP manufacture of tablets for early clinical development

manufacturing services required to enable a first-in-human clinical study within the Microbiome Health Initiative (MHI). The services include formulation development, analytical method development and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets), stability studies,

and preparation of documentation to support regulatory submissions (IND/IMPD). The work covers the full IND-enabling drug product package for a novel small-molecule compound within the bile acid class, intended for use in a Phase I human i