The 3 Steps In The FDA Regulatory Consulting Process

23 May 2023
 Categories: , Blog


Any organization that needs to achieve compliance with FDA standards for products or services wants the process to be as seamless as possible. Companies often hire an FDA regulatory consultant to guide them through the process. If you wonder what the FDA regulatory consulting process looks like, you should be aware of these three steps.

Project Assessment

The first step for any consulting effort is to collect data about the project. Whether you're developing a drug, medical device, manufacturing process, food, drink, or some other marketable item, the consultant needs to know what it is and figure out how it fits into the FDA's regulatory framework. The consultant then has a direction for acquiring clinical data, developing the initial indications, providing product specifications, and describing the intended use.

Notably, if there are mismatched between the product's current positioning and how the FDA is likely to see it, this is the time to address those issues. Depending on how much regulatory friction might arise, changes could be as simple as altering the indications or as complex as ordering new rounds of testing.


An FDA regulatory consultant will also assist you with developing the submission materials. Foremost, you'll need to identify the correct forms and send them to the right parties at the FDA. Secondly, you'll have to select supporting documents to help regulators understand what the product is and why your company believes the product is safe enough for the public.

The application process for many FDA approvals includes several layers. Especially if you're dealing with drugs or medical devices, prepare to go through preapproval processes or several phases of trials before getting to market.

Likewise, expect to communicate with the FDA a lot. An FDA regulatory consultant can help you answer questions in ways that clarify answers rather than create confusion.

Compliance, Post-Approval Updates, and Reviews

Many products under the FDA's jurisdiction will require documentation of ongoing compliance. Also, you'll likely have to update the FDA about real-world performance once the product hits the market. If the FDA has concerns about the product, you may also require consulting help to respond. In some cases, you might need to alter labeling and marketing to ensure that the public stays as up-to-date on developments as possible. Extreme cases may lead to recalls.

Regulatory status may also undergo periodic reviews. These are standard updates to verify that the product is still safe. More FDA regulatory consulting advice can be helpful for navigating the review process. For more information, contact a company like Compliance Insight.