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

Co-Founder & Operational Head

Umesh T. G.

Co-Founder & Technical Head

CMC experts

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.