GreyRigge Associates Ltd


GreyRigge Associates (GRA) is a biotech consultancy that works internationally helping both small and large biopharmaceutical companies in the development of their medicines. GRA offer both technical and commercial support for biotech products across a wide range of large molecule product types including vaccines (live attenuated, viral vector, inactivated, mRNA), gene and cell therapies, monoclonal antibodies, recombinant proteins and peptides. GRA offer both consultancy and training services to clients covering all CMC elements that include process & analytical development, formulation design & filling of biologics, quality assurance as well as non-clinical activities, including complex statistical analysis and support on CMC, non-clinical and clinical. GRA have experience in product characterisation and product stability evaluation, including specifications, supporting CMC elements together with their regulatory strategy & submissions. GRA are experienced in process characterisation and validation and the generation of process control strategies. GRA has expertise that includes scale down models and manufacturing developers. GRA are QbD practitioners, including advising on risk assessments and the appropriate use of statistics for experiment design to determine process operating ranges. GRA has broad experience of working with CDMO and CRO partners worldwide, advising and supporting organisations in the setup and management of their partners
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