FDA Due Dilligence Review
Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic company, you need to prepare for an FDA due diligence review. An FDA due diligence review is an opportunity for the buyer to review your company’s regulatory compliance, compliance history, and regulatory risk exposure, i.e., how likely is FDA enforcement action.
FDA due diligence involves three primary areas. They are:
- Pre-market compliance;
- Labeling; and
- Post-market compliance.
Pre-market compliance can include a range of activities. For
Labeling in any product category is more than the physical packaging but can extend to websites, social media, testimonials, paid reviews, and videos. Even Amazon reviews still pose a risk and merit review. A label review for each product category is looking for different issues but is key to any FDA due diligence review.
Post-market compliance focuses on
An FDA due diligence review is a multi-factor analysis that is specific to each company. Given the potential depth and complexity, it’s important to plan ahead.
FDA Due Diligence Review
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