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.

Module 1

This introduction to the program will address the importance of considering various regulatory and reimbursement requirements early on in the design and research process for any health care invention. We also address how the three tiers of consultation assistance will work to help you along the way to preparing your own preliminary regulatory, clinical research and reimbursement plans. 

Module 2

Although understanding the regulatory requirements for any health care innovation can be daunting, this module provides a step by step approach on how to determine that for your invention. We model the process around a medical device as an example, however a similar research strategy can be used to research the regulatory requirements for drugs or combination drug/devices as well. 

Module 3

The clinical research module will enable you to determine what protocol you are likely going to need to execute in order to achieve an approval or clearance from the Agency for your invention. Also, clinical trial management issues that typically result in delays in a trial's execution are addressed, and how to avoid them. 

Module 4

Digital health wearables, cell phone apps and predictive clinical decision support software has become a new high growth area in medicine. Here we address how to determine whether what you might be developing is regulated by the Agency or not; based on the recent 21st Century Cures Act legislation and the policy papers now emerging from the Agency to implement these new directives. 

Module 5

Although last in the series, reimbursement is something that needs to be researched right up front. Otherwise you might not do the right kind of clinical work to support eventual pursuit of reimbursement. In this video we offer some background on how the complex field of health care reimbursement works and some practical suggestions on steps to be taken to be successful in securing it.