DN Life Sciences

New Product development with CMC support & regulatory filings (INDs & NDAs& DMFs)

Non-infringing route of synthesis (ROS) development for exclusivity marketing opportunities under para-IV filings.
Generic route scouting/development & process optimisation & validations for DMF filings.
Safety study of the process.
Analytical method development, optimization, and validations.
IP generation and process patent filings.
CMC support for various regulatory filings.
Tech pack preparation and technology transferring to manufacturing plants.