Case Study
Strategic DHF DevelopmentThe Situation
Company: A small biologics firm preparing to submit their first Investigational New Drug (IND) application.
Issue: As a first-time sponsor, the client was entering unfamiliar territory, especially in terms of regulatory expectations and documentation for drug-device combination products. Their goal was to enable their first Phase 1 IND submission—including a delivery device—with confidence and minimal regulatory risk.
Project: Develop a streamlined Design History File (DHF) and targeted submission-ready content that met regulatory expectations without overengineering the program.
Challenges Expressed:
- The internal team had minimal experience with combination product development.
- The regulatory pathway for combination products was unclear to them.
- They lacked internal resources and processes to build compliant documentation from scratch.
Impact:
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Internal uncertainty and concern about whether their documentation would withstand regulatory scrutiny.
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Risk of delays and rework that could jeopardize IND timelines.
Discovery:
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The client was new to combination product regulations, and their team had deep technical knowledge of the molecule and delivery requirements
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There was no common framework for regulatory expectations or product development principles across departments, leading to inefficiencies.
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The client team was leveraging a pre-established platform but had not decided on a final delivery platform
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They wanted to ensure their device development effort was appropriately scaled and applicable their final product.
Solutions Implemented:
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A lean, baseline DHF tailored to their Phase 1 program.
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A comprehensive, phased combination product strategy.
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A clear pathway to scale the development and documentation for later stages without rework.
This approach helped the client move forward with clarity and confidence—ready to successfully meet their IND milestone, and with a foundation they can build on for future development phases.
