SOLUTIONS FOR CONSISTENCY EVALUATION OF GENERIC DRUGS

Target
  • Assessing the safety for clinical Phase I
  • Bioequivalency assessment
Technical package
  • Clinical research institution selection
  • R&D plan design
  • Project management and cordination
Clinical study/Solutions for consistency evaluation of generic drugs

R&D Team  Led by several repatriated pervious senior scientists from Pharma Multinationals in the U.S.

R&D Services  Provide full-range R&D services that assist pharmaceutical companies from initial idea conception to final drug product submissions

Expertise   Specializes in drug product R&D that requires extensive studies and researches on molecule’s solid state (e.g. polymorphs, salts and etc.)

RA Team  In-house Regulatory Affairs team that is in frequent communication with the U.S. FDA and Chinese FDA (SFDA)

Record  Excellent safety, regulatory and environmental compliance record