Our team often performs regulatory due diligence from an efficacy, safety and quality perspective on companies considered for potential mergers or acquisitions.

We have provided our expert opinion on many of the most publicized M&As in the food and wellness categories and have been directly involved in this capacity for transactions in excess of $700 million. Examples include:

Regulatory due diligence for potential mergers and acquisitions involves performing an in-depth assessment of the regulatory compliance status of a company, its products, and activities. Due diligence audits generally involve an extensive review of documentation and processes to understand risk, liabilities, and the overall level of compliance with applicable regulatory requirements.

Regulatory issues can be a significant drain on finances and personnel. For this reason, it makes good business sense to conduct a comprehensive audit prior to making a large investment.

Mergers and acquisitions can lead to the discovery of regulatory inconsistencies which can decrease the value of an entire product line or business. Some examples of these inconsistencies would be a lack of product market authorizations, inadequate complaint-handling systems, inconsistent labeling, or deficient safety or quality measures in the manufacturing processes.