M&A, Divestiture, IPO & Investor-Readiness Support

The Work

In life sciences and consumer health deals, regulatory and quality issues are consistently among the top three sources of deal risk — and they tend to surface late. A claim that doesn't hold under scrutiny, a quality system that won't survive an FDA inspection, a label that doesn't match the evidence, a pipeline asset whose pathway is more fragile than the IC was told: any of these can re-price a deal, slow a close, or land as a post-close surprise that consumes management attention for years.

RGM's founder led regulatory due diligence at Reckitt, including the diligence and integration work behind a first-in-class Rx-to-OTC switch partnership, and has carried regulatory accountability across 3,000+ marketing authorizations through transaction diligence and integration work. The experience covers both sides of the table: what buyers should be looking at, and what sellers should have already organized before a process begins.

The work is equally relevant for buy-side diligence, sell-side preparation, IPO readiness, and post-deal integration or remediation. On the buy side, the focus is identifying the regulatory and quality risks that the data room doesn't surface and pressure-testing the management story. On the sell side, the focus is making sure the regulatory and claims narrative will survive diligence — and that nothing in the file becomes a price-discovery moment in the second round. For IPOs, the focus is building the regulatory readiness story for prospectus and investor scrutiny.

Investor-readiness work, in particular, is about constructing the regulatory and claims story that holds up to a tough room. Boards and investors increasingly ask sharper regulatory questions than they did even a few years ago. The answers need to be ready before the questions are asked.