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.