GreyRigge Associates Limited Information

GreyRigge Associates is a leading biotech consultancy partner with sites in the UK, USA & Japan, bringing biopharmaceutical development experience. We offer consultancy support and training to small, mid-size and large companies, across the globe. GRA specialises in biopharmaceutical development covering early-stage product development through to late-stage development and ultimately product launch. Our expertise is ranges preclinical, CMC BDS and DP, product formulation, quality & regulatory support as well as clinical services. GRA Recent Projects: • CMC process & formulation development, including CDMO(s) management for peptides, therapeutic proteins, live vaccines and a novel recombinant protein • Analytical development & Stability management for monoclonal antibodies and antibody fragments, a bispecific antibody domain, therapeutic proteins, live vaccines, peptides, antibody drug conjugates (ADCs) and CGT from stem cells • CMC, SDM and MSAT regulatory support for mAb biosimilars, providing external review of the process and analytical characterisation, validation and other CMC BLA supporting activities • CDMO selection & Management and process development • Extractables & Leachables risk assessment activity • Cell based bioassay development for an ADC • Cell banking for a vaccine platform Our team of expert consultants enjoy working amongst a collaborative, supportive team of fellow experts. If you are: - a biopharmaceutical company looking for consultancy support or training, please contact us to see how we can help support you. - an investor looking at novel assets and require support in investigating opportunities, please contact us to discuss how we might assist you. - an experienced consultant open to freelance opportunities and could apply your expertise for GRA clients then please connect with us. Please follow us today to stay up to date with the latest happenings at GRA.