REGULATORY EXPERTISE (END TO END)

  • Drug Master File (DMF)- For Global Regulatory Authorities
    (US/EUROPE/CANADA/AUSTRALIA/NZ/AFRICA/MIDDLE ASIA/EAST ASIA ETC.)
  • CEP/COS(EDQM Submission)
  • Open Part/Closed Part DMF for Row Market
  • Risk Assessments
  • Electronic CTD (eCTD)
  • China/ Brazil/ Taiwan/ Korea/ Bangladesh DMFs
  • CADIFA Submissions ( Brazil Market )
  • CESP Login Creation
  • EMA/SPOR Registration
  • DUNS Registration
  • FEI Number Registration