Life Science Mergers & Acquisitions – Performing Effective Due Diligence

Monday, October 16, 2023

Source: Compliance Team

When companies are acquired or merge, inherent risk is involved. When FDA and international medical regulators enter the mix, the risks are multiplied. But, that’s no reason to disregard life science business opportunities. Higher risk life science deals also involve higher reward. However, such a transaction must be done intelligently with regulated industry boundaries in mind.

What if you had an “edge” in your M&A negotiations beyond understanding the financial risk of the transaction?  P&L statements only tell part of the story. Imagine if your target acquisition company neglected to make sensible, internal regulatory investments to avert expensive FDA enforcement actions.

Compliance risks in the life sciences extend beyond the first-order cost of remediating FDA enforcement actions.  Other risks include the hidden costs of uncovering and repairing poorly managed good manufacturing practices (GMP), good lab practices (GLP), or drug manufacturing validation programs after an acquisition has occurred. If the life science firm has international locations, the hidden cost of repairing compliance deficiencies to foreign regulatory agencies is compounded.

Our life science experts have spent decades preventing and remediating such compliance deficiencies within global and domestic pharmaceutical companies. Compliance Team can supplement your financial Due Diligence Review with a trusted program that that identifies covert compliance risks that we’ve managed in a variety of life sciences operations.

Let us help you estimate the true costs for repairing compliance shortcomings. If concerning deficiencies are found, we have the industry knowledge to outline true costs that may result if a regulator were to bring enforcement actions as a result. This helps you leverage a true price for your acquisition.

Our specialized industry knowledge allows us to identify subtleties that may be overlooked by an individual without significant experience in the pharmaceutical and medical device industry. Think of our service like hiring an inspector before purchasing commercial real estate, but we assist you in focusing on the regulatory status (or deficiencies) of the regulated business.

Whether you are considering a single acquisition, a bolt on acquisition, or merging with a life sciences company, the right knowledge will drive astute decision-making. We will provide powerful insight to enhance your negotiating power for the most favorable deal. Once the deal is complete, we also have the ground-floor expertise to facilitate any necessary compliance improvements.

We know that you know your business. We also know ours. We welcome the opportunity to augment your due diligence team to complete a successful life sciences M&A deal. It’s our job to help each of our partners avoid costly, regulatory setbacks.

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