We’ve been through the process countless times, and if we can give you any advice it would be this: The only way to de-risk your company and get to market with the safest product possible is to dot your i’s and cross your t’s.
Lucky for you, we are proud “i”-dotters & “t”-crossers.
Not only do we ensure that no stone is left un-turned as we guide you through the process, we’ll actually bully you to do it the right way even when you think it’s unnecessary! This is because our number one priority is your success, as well as the well being of the end users.
Flat-fee Pricing
Our flat-fee pricing ensures that our interests are aligned, so we are free to take whatever actions are necessary at each step to achieve our shared goal.
Phase.1
Your DNA Launch Plan
Every client starts with the DNA Launch Plan, a deep-dive into where you are in the product development life cycle. Based on our findings we will give you a plan for your best course of action to successfully navigate the approval process. With this plan alone you will be better positioned for success than without it.
2-3 Weeks
$4,999
Phase.2
Regulation Plan and Strategy + Gap Analysis
Based on the DNA Launch Plan, we will map out a detailed strategy to get your product to market. The Gap Analysis derisks your company’s future by catching problems that can lead to recalls down the line.
2 Months
$9,999 - $19,999
*(based on findings in DNA Launch Plan)
Phase.3
Quality Management System, Product Development Design Control Process and Risk Management
Based on the plan from Phase 2, we are here to implement the entire process with you, Developing your Quality Management System, Product Development Design Control Process and complete Risk Management.
3-9 Months
$29,999 - $184,999
