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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 services include:

  • Reviewing scientific data and setting regulatory submissions strategy
  • Creating messages and outlines
  • Identifying expert panelists that reflect  your audience
  • Testing regulatory strategy and clinical submission documents through expert panels
  • Developing realistic Q&As
  • Conducting  on camera role-plays and 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® pharmaceutical FDA advisory committee meeting preparation process, 3D's experienced team of pharma consultants work side-by-side with you and your team.

3D's FDA preparation services include:

  • Reviewing scientific data and set AdCom prep strategy
  • Profiling FDA advisory committee members
  • Creating messages and script the written AdCom presentation
  • Writing Qs and As
  • Conducting on-camera role-play and constructive critique
  • Creating PowerPoint data slides and QC validation of data
  • 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.