Investigational New Drug Application Support

When faced with industry pressures, companies turn to Halloran for essential support in their initial investigational applications. We provide a roadmap to ensure your product's market plan is grounded in expert guidance. Our regulatory expertise helps identify gaps in your current program, extend leadership and technical support during application reviews, and offer coaching for effective FDA communication and interaction.

Our services cover a wide range of application types, providing clear insights into regulatory guidances and pathways. Once a regulatory strategy is agreed upon, Halloran collaborates with your team to implement it. We advise on the development of clinical trial documentation (INDs/IDEs, CTAs, etc.), or we can act as the authoring team to develop the content for you. We ensure the investigational application reflects the right approach at each stage of development.