Dossier Compilation &
Regulatory Support

At Rubicon, our regulatory team has a sound understanding of the global regulatory requirements. Rubicon’s in-house team of regulatory experts facilitates meeting challenging timelines and our processes are designed to provide cost effective study management solutions towards regulatory authorizations.

We provide the following regulatory services:

  • Provide strategies to obtain effective and efficient pathway towards required regulatory approvals
  • Submit dossiers to USFDA and EU authorities for approvals
  • Address deficiency questions & generation of data during registration phase