Proactive planning. The right relationships. Streamlined success.

Our therapeutic area heads and Chief Medical Officer Gus De Moraes, MD, PhD, MPH, work closely with clients to navigate all aspects of the regulatory process — optimal study designs, CMC, endpoints, patient population, site selection, monitoring methods and data capture.

As part of this support, Ora’s regulatory writing team will draft any documentation needed.

With over 85+ approvals to date, our senior staff meet frequently with domestic and international regulatory agencies (FDA, PMDA, EMA, etc.) on behalf of sponsors to plan proactively for success.