GreyRigge Associates (GRA) is a biotech consultancy company that works internationally helping both small and large biopharmaceutical companies to develop their medicines. GRA offers both technical and commercial support for biotech products such as vaccines, cell therapies, monoclonal antibodies, gene therapies and diagnostics. GRA offers both consultancy and training services to clients covering CMC, process and analytical development, formulation of biologics and pre-clinical and clinical assay development.  GRA also have experience in product characterisation and supporting the CMC elements of regulatory submissions and interactions.  GRA applies QbD practices to processes, advising on appropriate use of DoE.