Generics

Generics

The key steps in generic product development

  • Characterization of the reference product (Innovators Product)
  • Design of pharmaceutical equivalent and bioequivalent product
  • Design of a consistent manufacturing process
  • Pivotal Bioequivalence study

CuriRx can help with developing generics by improving the science underlying quality by design for the development and manufacture of the generic product. We have the expertise in improving the efficiency of existing methods or develop new methods for assessment of bioequivalence of products and for characterizing complex drug substance and products. Our expertise also includes developing lyophilization process parameters, deformulation or Reverse Engineering of generic small molecule formulation. Our scientists will separate and identify the chemical composition of complex mixtures. Our analysis will also attempt to quantify the different components of the sample. Our experience scientists will use the latest methods for unraveling the formulations with complicated excipient ratios.