IND Success Strategy: Building A High-Quality IND From Scratch With Strategic Gap Analysis

A biotech sponsor lacking in-house regulatory expertise engaged Veristat to create and submit its first Investigational New Drug (IND) application. Without prior submission experience, the sponsor risked delays or a clinical hold due to incomplete documentation.

Veristat applied its proven, end-to-end IND development model—beginning with a regulatory gap analysis to identify missing information, aligning content with FDA expectations, and assembling a cross-functional project team. Services included strategic regulatory review, medical writing, project management, and electronic publishing (eCTD). Veristat coordinated with third-party CROs and scientific consultants to integrate technical data, author ICH-compliant summaries, and produce core IND documents. By managing timelines, harmonizing vendor deliverables, and ensuring scientific and regulatory consistency, Veristat delivered a complete, FDA-compliant IND dossier on time. This proactive approach eliminated critical deficiencies, prevented potential review delays, and enabled the sponsor to initiate clinical trials with confidence—supporting both regulatory success and corporate milestones.