All regulatory communications have data.
Successful communications have a story.

Identify and align with FDA on objectives for key clinical milestones.
Obtain clear direction on FDA concerns and priorities.
Convey clinical program progress with a credible scientific narrative.

That’s where 3D comes in. 3D helps you

• Leverage regulatory precedent and scientific materials to anticipate and proactively address potential FDA concerns.

• Write briefing documents and related submission materials that convey a concise and cohesive scientific story.

• Develop Q&A playbooks that drive discussions to address FDA issues and achieve shared objectives.

We work with you to ensure your FDA interactions are focused and constructive, paving the way for efficient clinical development and clear regulatory objectives.

_{BLA = Biologics License Application; EOP2 = End of Phase 2; IND = Investigational New Drug; NDA = New Drug Application; PMA = Premarket Approval}

Our Latest Thinking

• Leveraging Communications To Help A Nonprofit Stand Out And Motivate Donors To Give – And Give Some More – To The Cause
• Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock
• CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections

Regulatory Communications at Your Fingertips

How We Work