Capabilities::Regulatory

At Marck, 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