We support customers with regulatory expertise along the entire drug development process, while also anticipating regulatory shifts. This positions us as an ideal strategic partner for the development and manufacture of next-generation pharmaceuticals and biologics.
5
state-of-the-art facilities with approval from major regulatory agencies
20
years of proven regulatory compliance with 138 successful audits
100%
regulatory inspections passed without any critical observations
By delivering comprehensive data packages with thorough analytical assessment and characterization, we help customers with global regulatory submissions. We also execute multiple clinical and commercial manufacturing campaigns for successful regulatory approvals, and have expertise across various regulatory pathways, including New Chemical Entities (NCE-1), Paragraph IV (PARA IV), Abbreviated New Drug Applications (ANDA) and 505(b)(2) formulations.#
When it comes to our facilities, there is no room for compromise. That’s why we have received approval from several global regulatory bodies for many of our facilities, including the FDA, EMA, ANVISA, TGA and Health Canada. Currently, we operate five state-of-the-art facilities in Bengaluru, India, which speak for our commitment to excellence. And we have plans for future expansion coming soon.