Regulatory Submission

Using the time between submission and clearance to build commercial momentum.

 

A submission without a commercial strategy in development is an opportunity lost. While your submission is under review, there is critical commercial work to be done—and the innovators who use this time well arrive at clearance ready to move immediately. We help you plan for commercial launch and engage early stakeholders while your submission is under review.

We help you develop HCP pre-awareness campaigns, refine payer and health system messaging, and build the commercial assets your team needs to launch with confidence the moment clearance is granted. Arriving at clearance with your commercial strategy in place is the difference between a slow start and a strong one.


Our Approach

We help biomedical innovators achieve their long-term objectives 

 

We are masters at helping biomedical innovators understand what their brands are and what they need to be in order to meet their strategic objectives. From complex brand architecture to persona development, competitive positioning to customer experience management, articulating brand promises to establishing creative platforms; we immerse ourselves in our clients’ worlds, regardless of industry, and respond thoughtfully to their brand challenges and marketing needs.

Discovery

 

We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.

APPROXIMATE TIMING: 1-2 DAYS

 

Assessment

 

We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.

 

Approximate Timing: 1 week

 

Statement of Work

 

We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, cost, and key milestones.

 

Approximate Timing: 1-2 weeks

 

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Your innovation Just Might change the world. But is your brand up to the task? We help you turn Just Might into Just Mighty.