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New resources! Looking to scale your DHT in global markets? Explore DiMe's new International Regulatory Pathways resources.

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Work with DiMe on an upcoming project

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Good regulatory strategy is good business strategy

Build a fit-for-purpose regulatory strategy for better commercial decision-making and success.

Develop your regulatory strategy

Regulatory Strategy for Digital Health Products in the U.S.
A comprehensive regulatory strategy is critical for the success of digital health products. Now that you’ve identified your appropriate pathway, use these toolkits to carefully plan and implement a low-risk, successful regulatory review process that integrate into your overall business plan.

Identify

Use the RegPath tool and other resources to navigate and identify your regulatory pathway.

Build

Create and integrate a fit-for-purpose regulatory strategy into your business plan for commercial success.

Interact

Ongoing, interact with regulators to develop digital health products that best meet your goals and patients’ needs.

Join our next project

Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

Join the Integrated Evidence Plans project

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