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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.

Regulatory Leadership Crafting efficient regulatory pathways tailored to your product's unique aspects.

Regulatory Support and Project Management Managing document workflows, compilation, and submission timelines.

Gap Assessment Identifying and addressing program development gaps before IND submission.

Document Preparation and Review

Ensuring clarity, coherence, and compliance with FDA guidelines.

FDA Representation and Interaction Serving as authorized representatives and providing coaching for FDA communication.

Diverse Application Types Handling various application types, including academic-sponsored, commercial-sponsored, and compassionate use INDs.

By partnering with Halloran, you benefit from the strategic advice of seasoned regulatory professionals who have frequent FDA interactions, enhancing your application's chances of success. Our expertise extends to nonclinical program assessment, clinical trial protocol design, data management, quality assurance, and effective communication with regulatory authorities.

Our track record speaks for itself, with over 20 original IND applications submitted annually and numerous successful "Study May Proceed" letters obtained. We are committed to supporting your IND application journey with tailored regulatory services, providing the successful development and approval of your investigational drug.

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