With the global market for biogenerics getting bigger, wider and worth over a US$100 billion, we have set our sights to tap this business opportunity. And to this end, we have built comprehensive concept-to-market capabilities for biogenerics for the international markets.

A sound regulatory infrastructure has been set up for our biogenerics pipeline, with registrations in developing as well as developed markets, such as the US and Europe.

With a basket of recombinant brands, we are making forays into regulated, non-regulated and less regulated markets. We are also rapidly progressing with clinical trials in some of the developed countries, to tap future business opportunities.

Our expertise in Corporate Regulatory includes
  • Well experienced team for Global Regulatory Affairs for Drug Product and Drug Substance
  • Regulatory expertise available for US, Europe, Australia, Canada and Rest Of the World
Bio Marketing
  • Experienced and focused team for Biotechnology, New Chemical Entities and ANDA products
  • Experience in handling Pre-IND meetings for 505(b)(1) and 505(b)(2) applications with FDA and Scientific advisory meetings with European agencies
  • Capabilities for DMF, ASMF and CEP for the Active pharmaceutical ingredient (API)
  • Experienced in handling registrations for various dosage, forms such as Solid orals, Injectables, Ophthalmic, Liquid orals and Biotech products
  • Regulatory compliance in the manufacturing facilities approved by US FDA, UK MHRA, Brazil-ANVISA and other international regulatory agencies