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International Regulatory Services & Advisory

  • Documentation / Dossier Preparation, Review and Advisory for RA Compliance
  • Preparation of DMFs (CTD), IND, ANDAs (CTD, ACTD ) for US and other Regulated Markets
  • Review of Dossiers for their correctness and completeness
  • Product Registration Dossiers for ROW Market
  • Prepare query responses on submitted dossier
  • Obtaining MA using the most suitable regulatory pathway


  • Vendor’s Dossier Audit
  • Arranging for European QP Audit
  • Participation in Pre-qualification program for WHO Geneva & other International Procurement Agencies
  • Renovations / Upgradation of Existing Manufacturing Facility for Global Regulatory Compliance