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IND Success Strategy: Building a High-Quality IND from Scratch with Strategic Gap Analysis

Clinical Trial Regulations Strategic Consulting

Learn how our regulatory affairs team was able to work with a sponsor to build a complete, FDA-compliant IND from scratch. Our collaborative efforts led to successful IND submission and initiation of clinical trials with confidence, preventing potential delays and clinical holds.

A sponsor without internal regulatory expertise needed to create and submit an Investigational New Drug (IND) application and turned to Veristat for comprehensive support. They required in-depth regulatory guidance to ensure a compliant IND submission and smooth development process moving forward, knowing that missing or incomplete documentation could cause costly delays.

👉 In this case study, learn how our regulatory team was able to work with the sponsor to solve challenges across numerous areas including:

  • Strategic gap analysis

  • IND planning and management

  • Medical writing coordination

  • Document authoring

  • eCTD publishing

  • FDA submission support

Download our complete case study "IND Success Strategy: Building a High-Quality IND from Scratch with Strategic Gap Analysis"
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