Our regulatory affairs team has extensive experience in CMC, cGMPs and quality management and is ready to support IND and BLA application. Our understanding of requirements of FDA, EMA, NMPA and other regulatory authorities ensure regulatory compliance in R&D and registration.
13 months from gene synthesis to GMP level drug product, including one month of stability data, a proven drug development platform across all CMC activities.
Experience in commercialization of more than 5 products, including two Covid19 vaccine products. 11 months from the preparation of clinical phase III information to the end of process validation
We provide support in preparation of Common Technical Document (CTD) for clinical trials application of drug product.
