3 Ways An FDA Regulatory Consultant Can Help Market Your Medical Products

Posted on: 28 October 2021

Today's pharmaceutical companies are operating within a global economy. This provides a wide range of options when it comes to marketing the medical products each company develops.

The Food and Drug Administration (FDA) closely monitors the marketing of any medical product manufactured in the United States. An FDA regulatory consultant, like the team members at Compliance Insight, can help you ensure that your marketing efforts meet stringent FDA standards so that your pharmaceutical company can become as profitable as possible.

Here are just three ways a regulatory consultant can help you market your products:

1. Label Review

All medical products marketed in the United States are required to be labeled. The label attached to each product must contain some very specific information in order for the label to comply with FDA standards. An FDA regulatory consultant can review your company's label mock-ups before production begins.

The consultant will verify if the label can be attached securely to your product, whether the label is clear enough, and determine if your company's production and storage systems will ensure that the correct label is applied to each product. It's more cost-effective to make changes to a label mock-up than it is to recall medical products due to labeling errors.

2. Marketing Material Review

In addition to reviewing your product labels, an FDA regulatory consultant can inspect your marketing materials to ensure they comply with FDA marketing standards. Failure to maintain a high level of consistency could result in the FDA revoking the approval for your medical products.

An FDA regulatory consultant can also help you prevent errors in your marketing materials from compromising the success of your medical products. The information that is included in marketing materials must be consistent across all mediums. This means that all of your television and radio advertisements, brochures, websites, and press releases need to contain the same information.

3. Obtain CE Marking Certification

Many pharmaceutical companies want to sell medical products in both the United States and Europe. In order for these medical products to be eligible for European markets, they must feature a CE mark. This mark signifies that the product complies with European safety standards and will not cause any harm.

Some products are eligible for self-declaration when it comes to CE marking, but medical products must be reviewed by a notified body and receive a CE marking certification. An FDA regulatory consultant will be intimately familiar with the CE marking requirements your products must meet, and they can guide you through the certification process as you prepare to market your medical products in Europe.