Compliance Mistakes That Kill Pharma and Biotech Deals

Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions.

When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival.

Darshan explains how regulators—particularly the DOJ and FDA—expect compliance to be fully integrated into M&A due diligence. The DOJ’s Corporate Compliance Guidelines make it clear: compliance needs to be evaluated both before the acquisition and after the acquisition, because any lapses can lead to penalties, successor liability, or even personal liability for executives and investors.

He highlights that compliance red flags don’t just stall deals—they can change valuations, shift negotiation leverage, or cause buyers to walk away entirely. On the other hand, strong compliance systems can actually enhance a company’s attractiveness, helping reassure investors and acquirers.

Darshan also breaks down how OIG and FDA expectations, successor liability rules, and even global compliance standards all converge to shape the M&A landscape in life sciences. And for private equity? The message is simple: compliance isn’t a checkbox—it’s deal insurance.

The key takeaway? In life sciences M&A, compliance can make or break your investment. If you get it right, you buy not only a company but also credibility and long-term sustainability. If you get it wrong, you might inherit a regulatory nightmare that no deal price can fix. 

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