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.
RELATED INSIGHTS
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Success Planning for an Original NDA / BLA Submission
This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate […]
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Bringing In Vitro Diagnostics to Market with Real-World Evidence
In vitro diagnostic (IVD) devices are a unique type of medical device. Although they meet the definition of a medical device, they are not intended to treat a disease or condition. Rather, they are the instruments or reagents that analyze samples taken from patients. IVDs are less invasive than traditional medical devices, but still present […]
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Preparing Now for FDA’s START Program for Rare Disease Drug Developers
On September 29, 2023, the U.S. Food and Drug Administration (FDA) took action to help further accelerate the development of novel drug and biological products for rare diseases. The action, an announcement of an opportunity for a limited number of sponsors to participate in a pilot program (Support for Clinical Trials Advancing Rare Disease Therapeutics […]
