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.