Efficient coordination & comprehensive eCTD Publishing and Submission services for pharmaceutical applications worldwide.

  • Original ANDA (Abbreviated New Drug Application)
  • Original NDA (New Drug Application)
  • Original IND (Investigational New Drug)
  • Original BLA (Biologics License Applications)
  • Original DMF (Drug Master File)
  • Original ANDS (Abbreviated New Drug Submission)
  • Original NDS (New Drug Submission)
  • Initial MAA (Marketing Authorisation Application)
  • Initial CEP (Certificate of Suitability)
  • Initial ASMF (Active Substance Master File)
  • Pre-Approval Amendments (Information Request, Complete Response, Discipline Review Letter, Validation Response)
  • OPDP Ad-Promo Submission
  • IND Safety Report
  • CMC Supplement
  • Labeling Supplement
  • Efficacy Supplement
  • Annual Report
  • PADER/PSUR
  • Renewal
  • Variations
  • Extension
  • Product Correspondences
  • Withdrawal
  • Clinical Trial Application (CTA)
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