What is Regulatory Strategy?

If you are considering bringing your innovation from the academic bench to patients in the community, then you must first successfully navigate through the FDA’s complex regulatory approval process.

Even if you believe that you have discovered a cure for cancer or designed an app that significantly reduces depression, the way you design your regulatory submission will determine if your concept will ever make it to patients.

A regulatory strategy is a formal document that aligns regulatory activities with the business strategy that will bring the innovation to patients/market.

The Georgia CTSA is here to help demystify the process of developing a regulatory strategy and provide specific project guidance through our 3-tier RegCheck program:


Tier 1 – Self-Guided Intro
We have created a series of informational videos to provide an overview of the process so that you can draft first a regulatory strategy and then a comprehensive regulatory plan which describes the specific steps and action required to successfully meet the regulatory strategy objectives.

Tier 2 – Regulatory Strategy Document Review
Once you have created a draft regulatory strategy, you may submit a request for a consult through the “Consult Request” link below. Your plan will be reviewed by a CTSA team member and guidance will be presented during a review meeting.

Tier 3 – Comprehensive Regulatory plan  
Once you have made the necessary updates to your plan, you may apply for a CTSA grant that will cover the costs of a professional regulatory consultant to review your plan and generate a 1 page “Regulatory Assessment” required by the FDA.