WHO WE ARE
We share state of the art experience in Quality by Design solutions w.r.t biologics, biosimilars and pharmaceuticals. Our proven tools have helped industries to increase the success rate at R&D and manufacturing. We understand the complexities of upstream, downstream, formulation, product & process characterization, analytical methods, scale-up, technology transfer and manufacturing.
Vikrama N. Prabhu
Umesh T. G.
Our team will deliver all the components of ‘Quality, Module -3’ of e-CTD submission.manufacturing. Our solutions are inline with USFDA, EMA, PMDA and other agencies expectations.