All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Overcome regulatory challenges and disputes—and create your pathway to approval.
Identify obstacles to addressing FDA concerns.
Leverage viable solutions to determine communications strategy.
Effectively communicate to reach a regulatory pathway forward.
That’s where 3D comes in. 3D helps you
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Analyze regulatory history and external precedent to inform your strategy and story.
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Develop clear, concise written and spoken materials that help focus your message and resolve disputes effectively.
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Provide realistic, scenario-based role-play to help you communicate with confidence.
We work with you to turn your greatest regulatory challenges into new opportunities for successful outcomes.
“3D put us through the paces, challenging us every step of the way. Because of their rigorous preparation, knowledge, and unwavering support, our little company stood up to the FDA, got our dispute resolved, and now has an approved product that’s making a difference in peoples’ lives.”
Mike Raab
President and CEO
Ardelyx, Inc.
CRL = Complete Response Letter; FDRR = Formal Dispute Resolution Request; MDL = Medical Device Listing