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Clinical and Regulatory Strategy

3D’s experienced team of science and communications consultants and rigorous 3D A•C•T® preparation process can guide your team in developing critical parts of your NDA, BLA or PMA clinical submission documents.

3D’s FDA Submission Services include:

  • Reviewing scientific data
  • Setting regulatory submission strategy
  • Creating messages and outlines
  • Identifying expert panelists who reflect your audience
  • Testing regulatory strategy and clinical submission documents through expert panels
  • Developing realistic Q&As
  • Providing constructive critique

“The 3D team is fabulous!  They gain subject matter expertise quickly, work collaboratively, roll up their sleeves and work side-by-side with company personnel, and offer great value. I can’t recommend them highly enough.”

Martha Morrell, MD
Chief Medical Officer

FDA Advisory Committee Preparation*

Using our proprietary and innovative 3D A•C•T® Advisory Committee meeting preparation process, 3D’s experienced team of science and regulatory consultants work side-by-side with you and your team.

3D’s FDA Advisory Committee preparation services include:

  • Reviewing scientific data and set ADCOM prep strategy
  • Profiling FDA Advisory Committee members
  • Creating messages and scripting the ADCOM presentation
  • Writing Qs and As
  • Conducting on-camera role-play and constructive critique
  • Creating PowerPoint data slides
  • Providing and training your team on all equipment for immediate slide recall
  • Ensuring version control across teams

*3D partners with our European colleagues to provide similar preparation services for EMA Oral Hearings.

Download the overview of our winning approach for Pre-Submission Consulting with FDA and EMA, FDA Advisory Committee Meetings, and CHMP Expert Group Meetings.

FDA Regulatory PDF

EMA / CHMP Regulatory PDF