The Investigational Drug Application (IND) and Investigational Medicinal Product Dossier (IMPD) mark a major milestone for drug candidates – namely, the ability to begin human clinical trials in the US or Europe, respectively. Creating a complete application that can satisfy the regulatory agencies is a substantial undertaking, requiring the input of Subject-Matter Experts from many areas, including Chemistry, Manufacturing and Controls (CMC), Drug Metabolism and Pharmacokinetics (DMPK), Toxicology, Clinical Operations and Strategy, and Regulatory Affairs. Coordinating the IND effort requires an understanding of how each section of the dossier supports the overall submission, the necessary content and level of detail required, and how to address limited data on the investigational drug at the time of submission.
With over 25 years’ experience in authoring, reviewing, coordinating and submitting INDs and IMPDs, we can guide your company smoothly through the planning, writing, review and submission of your IND and/or IMPD. If you haven’t yet had a Pre-IND Meeting with FDA, we can help you request the meeting, define the questions to be asked, and prepare the briefing document in advance of the meeting.
If you need assistance authoring CTD Module 1 (Region-specific Administrative Information), Module 2 (Overall Summaries) or Module 3 (CMC), we can help with some or all of the necessary module creation. We can also assist SMEs in creating Module 4 (Nonclinical) and Module 5 (Clinical), including review and formatting of each module.
If you’d like to discuss how E4 Consulting can facilitate your successful IND or IMPD, please contact us.