Regulatory Services

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At Amanta, we have a dedicated & qualified team to handle various functions of regulatory affairs. Some of our identified strengths are:

  • Compiling & providing a complete range of regulatory documents suitable to the client’s requirement
  • Filing & preparing dossiers in consultation with the client’s regulatory group for semi-regulated & advanced markets
  • Tracking the submissions with different regulatory bodies & complying to the technical queries
  • Facilitating efficient interaction with regulatory bodies & client’s regulatory group
  • Liaisoning with FDA & other governing bodies for getting necessary product permissions & other “quality” related certificates
  • Updating our client on changes and affecting the changes (if any) by the different regulatory bodies
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