Regulatory Services Pre-Submission Services

  • Registration and self-identification i.e. D-U-N-S number, FEI number request
  • Compilation and Investigational New Drug - IND Application
  • Compilation and New Drug Application - (NDA)
  • Compilation and Abbreviated New Drug Application (ANDA)
  • Compilation and Investigational Medicinal Product Dossier (IMPD)
  • Marketing Authorization Application (MAA) to Europe via appropriate procedure
  • MAAs for Biosimilar product
  • Certification of suitability for EU
  • Dossiers for emerging countries (RoW market)
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