Companies often risk label restrictions or outright rejection by regulatory authorities because they failed to understand and deliver what the agencies really wanted. 

To optimize clinical development discussions and negotiations with the FDA and EMEA, companies must clearly envision their long-term commercial needs early in the development process.  This vision should guide clinical protocol development, endpoint selection, data collection, enrollment criteria and other key decisions. 

3D Communications uses proprietary tools and tested processes to help your team articulate their strategic vision and prepare for important meetings with regulators. We have developed 3D ACT™, the industry’s premier full-service process for regulatory meetings.

ANALYSIS                      

3D will work with you to clearly identify your long-term goals, product positioning, and specific objectives for each meeting. We help teams focus on what they want to achieve, anticipate regulatory questions and concerns, and formulate a plan for success.

CONTENT DEVELOPMENT
3D scientists and seasoned scientific writers will work with you to translate complex data into clear messages that put the science in context.  We will also help you develop data-driven answers to tough questions and compelling slides. Using Mind Mapping and the 3D Message Pyramid™, we ensure the data are woven into clear and comprehensive messages that inform and persuade.

TESTING
The 3D testing process helps teams prepare and sharpen their messages in the face of tough regulatory challenges.  Our proprietary KOLLEAD™ database identifies experienced clinical and regulatory experts to examine, interpret, and challenge your data.  3D experts work with you to hone content in an iterative fashion and develop decision-tree contingency planning – with clearly established “acceptable” and “unacceptable” outcomes. 

The result:   Your team will be confident, credible, and poised to succeed at each regulatory meeting.