The development of quality control methods is the basis for any GMP-compliant API process.
We do the preliminary analytics during the feasibility studies or route scouting. But only after the synthetic route is finalised, and the GMP starting materials are determined, can the real analytical development be launched.
We’ll develop quality control methods for starting materials, reagents, solvents, intermediates, and the API itself. Then, the methods will be fully validated, and we’ll provide you with the appropriate reports.