Regulatory Support

Regulatory Support

Kemwell, with facilities in India and Sweden, has extensive expertise in quality, compliance and regulatory affairs in both eastern and western markets. Our Development team’s Quality group offers regulatory support and assistance for:

  • EMA guidance
  • USFDA guidelines
  • ICH Guidance
  • Regulatory audits
  • Drug dossier preparation
  • CMC report for IND, NDA, and ANDA submissions
  • Product development strategy