Glossary

International Conference on Harmonization (ICH)

02.27.12

Full name: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH brings together the regulatory authorities of Europe, Japan and the U.S. and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during R&D. Also known as International Committee on Harmonization.
  • Contract Manufacturing Organization (CMO)

    A company that offers manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trials purposes and commercialization.…
    02.27.12

  • Contract Development and Manufacturing Organization (CDMO)

    A company that offers both contract drug development and manufacturing services. Comprehensive services range from early-stage R&D services such as synthesis, scale-up, formulation development, stability studies and method development all the way thr…
    02.27.12