Investigational New Drug Application

An original Investigational New Drug (IND) application submission marks a significant milestone in your development journey, representing years of dedication from numerous contributors. At Halloran, our mission is to facilitate the seamless transition of your development candidate from research and discovery to human clinical trials. With a shared commitment to addressing critical unmet patient needs and improving human health, we offer tailored regulatory support to ensure your IND application is anchored in expert guidance.

Our regulatory services cover a broad spectrum, ranging from acting as the authorized Sponsor contact with the FDA to providing strategic regulatory planning, project management support, and Electronic Common Technical Document (eCTD) submissions. Leveraging our combined expertise in diverse areas, including small molecules, biologics, advanced therapies, and specialized domains like oncology, immuno-oncology, neurology, and rare diseases, we tailor our approach to fit your specific needs.

Customization is at the core of our IND support services. Whether you require a full regulatory team or customized support, we adapt to meet your requirements. Our dedicated teams offer functional regulatory leadership, regulatory workflow organization, and submission compilation support, ensuring seamless execution throughout the application process.