How Can an FDA Compliance Consultant Help My Company?

The Food and Drug Administration (FDA) issued over 15,000 warning letters in 2017. If your company must adhere to FDA regulations, this reflects the challenges of FDA compliance.

But don’t fret! It’s easy to find help. Consider hiring an FDA compliance consultant.

Have you heard of an FDA consultant? Maybe you don’t see the need if you are not currently under FDA scrutiny. Don’t make the same mistake as the thousands of companies that get warning letters each year!

Read on to learn all about how FDA compliance consultants can help your company.

What is an FDA Compliance Consultant?

An FDA compliance consultant checks that your quality management system follows FDA regulations. Many organizations wait until they are facing FDA action before they hire an FDA compliance consultant. But an FDA consultant should be hired by any company regulated by the FDA.

Are you looking to overhaul your quality management system? Or maybe you want to tweak it to keep up with the latest regulations, you may want to hire one. These are some way an FDA consultant can help.

If you don’t want to overhaul your system, hire a consultant familiar with yours. If you do want a remodel, a good consultant can direct you to an optimal system for your current needs.

Why Do You Need an FDA Compliance Consultant?

So, what are the main benefits of hiring an FDA compliance consultant? First of all, they will help you stay updated on the current FDA rules and regulations. These guidelines are always changing, so having a dedicated individual to keep track of these can be a life and time saver.

A related benefit is that you have a direct liaison with the FDA. That way, any concerns you have about current policies can be quickly addressed.

Likewise, they can help you be better prepared for the inevitable FDA audits and inspections your business will face. It’s much better to receive corrections by your FDA compliance consultant to fix them early on instead of facing a fine later! Your consultant will also devise a plan to fix any deficiencies they notice.

If you do have any deficiencies due to an FDA audit, it’s not too late! These consultants are often hired by companies to help take corrective action after warnings provided by the FDA. They can help you revise any manufacturing, operating, and training procedures that the FDA deems deficient.

Finally, it helps to have someone outside of your company to take a look at your quality control procedures. An outside hire might be able to see things you never noticed. They also can offer fresh approaches to problems you might be having.