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doi: 10.1016/j.neuron.2019.02.008 95 YeLBaeMCassillyCDJabbaSVThorpeDWMartinAMet al

Best Practices for Preparing an IND Application Engage regulatory experts early to guide study design and submission strategy Conduct internal reviews and gap assessments to ensure completeness Use standardized templates for clarity and consistency Maintain audit-ready records of all preclinical, CMC, and clinical data Plan for pre-IND meetings with the FDA to clarify expectations How BioBoston Consulting Supports IND Submissions At BioBoston Consulting , we provide end-to-end support for IND applications: Preparing and reviewing preclinical, CMC, and clinical documentation Developing comprehensive clinical protocols and investigator brochures Ensuring compliance with FDA regulations and GMP standards Conducting internal audits and gap assessments to reduce FDA queries Supporting pre-IND meetings and regulatory communications Maintaining inspection-ready documentation throughout the submission process Our expertise helps sponsors prepare robust, compliant, and efficient IND applications, accelerating clinical development

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Introduction The liver is the major organ that metabolizes alcohol in the human body, and chronic alcohol intake increases the risk of liver diseases, including fatty liver, hepatitis, and cirrhosis [1]