Investigational New Drug (IND) Application
How we help with Investigational New Drug (IND) Application
When faced with industry pressures, companies turn to Halloran to provide essential support for their initial investigational application, because we provide a roadmap for ensuring your product and its plan to market is anchored in expert guidance. Our expertise in regulatory can help you assess gaps in your current program development, extend leadership and technical expertise in their application review, and provide coaching for FDA communication and interaction.
Our services encompass a diverse range of application types, each with succinct insights into regulatory guidances and pathways. Once we have an agreed-upon regulatory strategy, Halloran our clients’ team members to implement the strategy. We advise you on the development of content for the clinical trial documentation (INDs/IDEs, CTAs, etc.), or we can stand in as the authoring team to develop the content for clients. We make sure the investigational application reflects the right approach for each client at each stage of development.
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