ANDA filing and official response to FDA and CFDA

Target
  • Drug registration applications comply with the regulatory requirements (US FDA or NMPA)
  • Accurate response to FDA or NMPA
Technical package
  • Preparation of ANDA applications that comply with FDA and ICH or CFDA guidelines
  • Filing ANDA applications to FDA through the Electronic Submission (ESG) /to NMPA
  • Submit product label information in SPL format to FDA/submit product label information to NMPA
  • Response to FDA or NMPA