CMC Services Overview
Moving your pharmaceutical program from the preclinical phase into clinical development requires synthesis, preparation and testing of your active pharmaceutical ingredient (API) or organic compound for administration in vivo. Frontage’s CMC services include custom synthesis and development of active pharmaceutical ingredients (APIs) and reference standards finished product development support to identify the optimal dosage form and analytical services to analyze many dosage forms for related compounds, dosage form assay, stability and other physico-chemical characteristics.
The cGMP manufacturing facility at Frontage was designed with the goal of producing solid oral dosage forms, as well as semi-solid, liquid and sterile products ranging from a few units up to 120 kg for solid dose, 350 kg for semi-solid and liquids and up to 100 liters for aseptic processes.
Additionally, our scientific and regulatory consulting group can provide the expertise needed to support the filing of INDs, NDAs and ANDAs with the Food and Drug Administration. Last but not least, Frontage scientists have the required knowledge and expertise to support the technical transfer of the process and analytical methods to the sponsor’s facility.
