Chemical Development Solutions

Chemical Development Solutions of GVK BIO provides a convenient, single-site distribution of infrastructure, thereby delivering a seamless and innovative transition of solutions from lab to pilot plant and bulk manufacturing, with speed and quality. We ensure quality in the process during the design and development phase by understanding the Critical Process Parameters (CPP) and Critical Material Attributes (CMA). Custom synthesis, including synthesis of reference standards, impurity markers and scaffolds, with rapid turnaround and competitive pricingProcess safety assessment to proactively identify potential hazardous reactions Rich experience in developing innovative process for the NCEs 10+ IND filing support/ year Scientists have an average of 12+ years of experience in process development 18 molecules in late stage/commercial 7 programs in Phase III for a top 3 pharma companies Cater to various sectors such as pharmaceutical, specialty chemicals and animal health industry Our facilities have been inspected and accredited by several global regulatory authorities and major pharma clients. Some of the authoritative bodies include FDA, European Directorate for the Quality of Medicines (EDQM), Ministry of Food and Drug Safety, Pharmaceuticals and Medical Devices Agency (Pmda)