All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
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<div class='collapse' id='tabContent2' data-parent='#tab-element'> Beat the odds and win at your FDA Advisory Committee meeting.
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Only the toughest projects go before an FDA Advisory Committee.
Not a problem. We have you covered. Our people, process, and technology help you stay focused, work smarter, and succeed with your most demanding and skeptical audience.
“Only use 3D if succeeding at an FDA ADCOM is essential. We’ve worked with them on every one of our advisory committees for the last 12 years. Their expertise, process, and work ethic are unmatched.”
Anne Phillips
Senior Vice President of Clinical, Medical, and Regulatory Affairs, US
Novo Nordisk
Our Latest Thinking
- Pink Sheet: Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions
- Delivering Under Pressure – How To Turn Your Data Into An Investor And Media Success Story
- To Zoom or not to Zoom? That is the Question: For the FDA and US sponsors, the answer may depend on the type of FDA meeting
Our proven process 3D ACT® is not magic. It's better.
Learn WhyOpen the door and win at your CHMP meeting.
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Presenting at closed-door CHMP meetings can be a daunting
experience.
That is, unless you partner with experts who have been “in the room” at CHMP. We’ll
help you develop and deliver a strong presentation and persuasive answers, so you
leave a positive impression with the committee as they discuss your product and decide its fate.
“3D was key to our success during our CHMP Scientific Advisory Meeting and Oral Explanation. Their awesome team effectively led, partnered, scrutinized our thinking, and improved our outcomes – daily.”
Will Lewis
Chairman & Chief Executive Officer
Insmed
Our Latest Thinking
- Taking a Strategic Approach Early to Overcome Regulatory Hurdles and Win Approval
- Pink Sheet: Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rare Event
- Secrets of a Speechwriter: A Thought Processor for Thought Leaders
Our proven process 3D ACT® is not magic. It’s better.
Learn WhyGet your regulatory strategy on track from the very beginning.
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Waiting for regulatory challenges to happen is a bad strategy.
Let us help you anticipate issues and shape your content, so it stands up to regulatory scrutiny. We work alongside you at every stage of the submission process to prepare and deliver clear and persuasive messages to regulatory authorities.
“3D’s science and regulatory experts partnered with us to synthesize years of complex data – transforming it into a clear and cohesive scientific story for our submissions.”
Michael Rozycki, PhD
Senior Vice President, Regulatory Affairs
Pacira Biosciences, Inc.
Our Latest Thinking
- Taking the “E-A-R-L-Y Train” for Crisis Management
- Active Listening Can Make You a Better Speaker: Part 1
- What Today’s Business Leaders Can Learn from a “Powerless” Woman Who Spoke Her Truth
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Regulatory Services at Your Fingertips
Strategic Communications
Extraordinary times call for extraordinary communications.
We transform the way you communicate.