At Rubicon Research, our regulatory team has a sound understanding of global regulatory requirements. Our 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:
- Strategies to obtain effective and efficient pathway towards required regulatory approvals
- Submit dossiers to US FDA and EU authorities for approvals
- Address deficiency questions and generation of data during registration phase