This contract involves the development and manufacture of dosage forms suitable for administration in preclinical and clinical evaluations. The work includes performulation studies, formulation studies, analytical methods development and validation, stability studies, packaging, storage and distribution of the drug products. The work to be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs). Data and documentation are to be prepared in a form acceptable to the FDA for inclusion in Drug Master Files (DMFs), Investigational New Drug (INDs) or New Drug Application (NDAs).
