Chemistry & Manufacturing Control (CMC)

Chemistry and Manufacturing Control (CMC) is the FDA term used globally to describe the data for the manufacture and testing of a medicinal product although this term has now been replaced by Pharmaceutical Quality/CMC.  In practical terms it covers a wide range of activities including process development, manufacturing development, analytical development, control charting, tech transfer, method validation and process validation.  Essentially, all of the activities required to successfully develop and manufacturing a biological medicinal product.

GRA’s core expertise is within CMC with proven expertise supported by a number of GRA associates that have years of experience covering process & manufacturing development, process validation as well as expertise in Quality Control (QC) and analytical development that includes control charting, tech transfer & method validation.  GRA continues to work across the globe with international organisations both large and small that include Takeda Vaccines, Ipsen Biopharma, FluGen & Mesoblast.