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
