Regulatory Expertise
Before a brand-name is ready for regulatory submission it must stand up to name safety scrutiny. Nomen Healthcare offers a full range of services to anticipate and circumvent regulatory issues.
We model the guidelines and criteria for the different regulatory bodies and assess their implications with healthcare professionals.
A successful brand development project is able to endure uncertainty and secure regulatory name approval from the FDA, the EMEA and other regulatory agencies. We model the guidelines and criteria for the different regulatory bodies and assess their implications with healthcare professionals to identify potential name-related prescription errors and patient safety risks. Our regulatory advisors interpret the research and provide a final recommendation on the name's risk profile supported by compelling data and rationale.
