--- title: When Is the Best Time for a Pre-IND Meeting? description: Understanding the optimal timing for a Pre-IND meeting can significantly impact your drug development program. Learn when to seek FDA feedback to enhance your IND submission readiness. image: https://hallorancg.com/hubfs/AI-Generated%20Media/Images/The%20atmosphere%20is%20focused%20and%20collaborative%20reflecting%20a%20serious%20yet%20dynamic%20approach%20to%20planning%20and%20strategy%20in%20the%20pharmaceutical%20industry-1.jpeg --- ![](https://hallorancg.com/hs-fs/hubfs/AI-Generated%20Media/Images/The%20atmosphere%20is%20focused%20and%20collaborative%20reflecting%20a%20serious%20yet%20dynamic%20approach%20to%20planning%20and%20strategy%20in%20the%20pharmaceutical%20industry-1.jpeg?width=300&name=The%20atmosphere%20is%20focused%20and%20collaborative%20reflecting%20a%20serious%20yet%20dynamic%20approach%20to%20planning%20and%20strategy%20in%20the%20pharmaceutical%20industry-1.jpeg) [Josh Wooten](https://hallorancg.com/insights/author/josh-wooten)May 29, 2025 11:21:46 AM1 min read # When Is the Best Time for a Pre-IND Meeting? * * Prior to submitting an initial Investigational New Drug (IND), sponsors can (and most likely should) solicit the FDA’s feedback on their planned development program and/or IND-readiness through a Pre-IND meeting. The timing of the Pre-IND meeting relative to the initial IND submission is dependent on the sponsor’s goals for the meeting, identified risks, and the novelty of their development program. The recommended timing for a Pre-IND meeting relative to initial IND submission is as follows: - Greater than one year: sponsors intending to rely on novel manufacturing strategies and/or nonclinical evaluations to support clinical studies. - Six to nine months: sponsors that have completed most of their IND-enabling nonclinical pharmacology/pharmacokinetics studies and early toxicology studies and are now seeking FDA’s confirmation of their planned, definitive toxicology studies and clinical study synopsis. Sponsors should also have a developed chemistry, manufacturing, and controls (CMC) plan and early manufacturing data. - Less than three months: sponsors with complete (or nearly complete) CMC and nonclinical packages, and a fully developed clinical study synopsis, seeking confirmation of the adequacy of their overall IND package to support human studies. - No Pre-IND meeting: sponsors pursuing an indication in which significant precedent exists and have not identified any potential risks during their development program. This also may be necessary when a sponsor cannot afford to delay their IND submission and/or alter their development program based on FDA feedback. *Halloran almost always recommends that sponsors have a Pre-IND meeting.* Halloran can help you determine the most appropriate timing for a Pre-IND meeting, support the development of your Pre-IND meeting package, and provide strategic input in preparation. [Learn more](https://hallorancg.com/services) about Halloran’s services and solutions.   [Josh Wooten ](https://hallorancg.com/insights/author/josh-wooten) ## RELATED ARTICLES ```json { "@context" : "https://schema.org", "@type" : "Organization", "address" : { "@type" : "PostalAddress", "addressCountry" : "", "addressLocality" : "Cambridge", "addressRegion" : "MA", "postalCode" : "02142", "streetAddress" : "245 Main Street" }, "knowsLanguage" : "en", "logo" : { "@type" : "ImageObject", "url" : "https://9483922.fs1.hubspotusercontent-na1.net/hubfs/9483922/Orange%20Tree%20Blue%20Text.png" }, "name" : "Halloran Consulting Group, a PLG Company", "url" : "https://hallorancg.com/insights/when-is-the-best-time-for-a-pre-ind-meeting" } ``` ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "abstract" : "Understanding the optimal timing for a Pre-IND meeting can significantly impact your drug development program. Learn when to seek FDA feedback to enhance your IND submission readiness.", "author" : { "@type" : "Person", "name" : "Josh Wooten" }, "dateModified" : "May 29, 2025 3 PM", "datePublished" : "May 29, 2025 3 PM", "headline" : "When Is the Best Time for a Pre-IND Meeting?", "image" : "https://9483922.fs1.hubspotusercontent-na1.net/hubfs/9483922/AI-Generated%20Media/Images/The%20atmosphere%20is%20focused%20and%20collaborative%20reflecting%20a%20serious%20yet%20dynamic%20approach%20to%20planning%20and%20strategy%20in%20the%20pharmaceutical%20industry-1.jpeg", "inLanguage" : "en", "keywords" : "[Articles, Regulatory CMC Support, FDA Guidances, Regulatory Affairs and Operations, regulatory strategy]", "mainEntityOfPage" : { "@type" : "WebPage" }, "name" : "When Is the Best Time for a Pre-IND Meeting?", "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://9483922.fs1.hubspotusercontent-na1.net/hubfs/9483922/Orange%20Tree%20Blue%20Text.png" }, "name" : "Halloran Consulting Group, a PLG Company" }, "text" : "Prior to submitting an initial Investigational New Drug (IND), sponsors can (and most likely should) solicit the FDA’s feedback on their planned development program and/or IND-readiness through a Pre-IND meeting. The timing of the Pre-IND meeting relative to the initial IND submission is dependent on the sponsor’s goals for the meeting, identified risks, and the novelty of their development program. The recommended timing for a Pre-IND meeting relative to initial IND submission is as follows: Greater than one year: sponsors intending to rely on novel manufacturing strategies and/or nonclinical evaluations to support clinical studies. Six to nine months: sponsors that have completed most of their IND-enabling nonclinical pharmacology/pharmacokinetics studies and early toxicology studies and are now seeking FDA’s confirmation of their planned, definitive toxicology studies and clinical study synopsis. Sponsors should also have a developed chemistry, manufacturing, and controls (CMC) plan and early manufacturing data. Less than three months: sponsors with complete (or nearly complete) CMC and nonclinical packages, and a fully developed clinical study synopsis, seeking confirmation of the adequacy of their overall IND package to support human studies. No Pre-IND meeting: sponsors pursuing an indication in which significant precedent exists and have not identified any potential risks during their development program. This also may be necessary when a sponsor cannot afford to delay their IND submission and/or alter their development program based on FDA feedback. Halloran almost always recommends that sponsors have a Pre-IND meeting. Halloran can help you determine the most appropriate timing for a Pre-IND meeting, support the development of your Pre-IND meeting package, and provide strategic input in preparation. Learn more about Halloran’s services and solutions.", "url" : "https://hallorancg.com/insights/when-is-the-best-time-for-a-pre-ind-meeting", "wordCount" : "354" } ``` ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Josh Wooten", "url" : "https://hallorancg.com/insights/author/josh-wooten" }, "dateModified" : "2025-05-29T15:22:05.703Z", "datePublished" : "2025-05-29T15:21:46.000Z", "headline" : "When Is the Best Time for a Pre-IND Meeting?", "image" : [ "https://hallorancg.com/hubfs/AI-Generated%20Media/Images/The%20atmosphere%20is%20focused%20and%20collaborative%20reflecting%20a%20serious%20yet%20dynamic%20approach%20to%20planning%20and%20strategy%20in%20the%20pharmaceutical%20industry-1.jpeg" ], "mainEntityOfPage" : { "@id" : "https://hallorancg.com/insights/when-is-the-best-time-for-a-pre-ind-meeting", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://hallorancg.com/hubfs/Orange%20Tree%20Blue%20Text.png" }, "name" : "Halloran Consulting Group" } } ```