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REGULATORY Affairs

Rubicon has a sound understanding of the global regulatory requirements. Rubicon provides regulatory services to facilitate all stages of drug development with a strategy to obtain effective and efficient pathway towards required regulatory approvals.

We routinely submit dossiers to USFDA and EU authorities for approvals and undertake all the follow-on activities such as such as addressing deficiency questions & generation of data during registration phase in the territory.

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.