From fraud and abuse investigations to U.S. Food and Drug Administration (FDA) compliance matters, there are a broad range of potential risks that must be uncovered and evaluated before a life sciences transaction takes place. Given the stakes involved in this highly regulated sector, thorough due diligence is crucial. Investors that neglect to evaluate the target’s regulatory landscape and compliance posture could be making a costly mistake.
Epstein Becker Green’s life sciences attorneys have extensive experience conducting due diligence. We provide private equity firms, acquiring companies, lenders, and other investors with a comprehensive evaluation of the risks accompanying their potential transactions.
Creating a Due Diligence Plan
Our seasoned attorneys guide our investor clients through the regulatory landscape and risk profile for each investment target, helping them scope their due diligence activities based on their risk tolerance and investment objectives. Once a diligence plan is in place, we leap into action, assembling cross-border and cross-functional teams of attorneys and advisors to effectively and efficiently identify potential risks to the target, its products and services, and its revenues.
Uncovering the Potential Risks
As part of our thorough regulatory due diligence reviews, our life sciences attorneys review regulatory inspection and enforcement history, marketing applications and approvals, sales and marketing activities, quality system and supply chain issues, and fraud and abuse and other compliance issues. Our experienced attorneys can easily spot any regulatory problems that could impact a transaction’s value or viability.
Keeping Clients Informed
During the due diligence process, we effectively communicate our findings, alerting clients of possible red flags. These findings play a critical role as clients craft their investment strategy, arrive at an appropriate purchase price, and create a post-closing integration plan. Our experienced life sciences attorneys also provide counsel throughout the integration process to help ensure a smooth transition.