M&A Due
Diligence

Every target looks clean in the data room index. We read what's actually in the files — and price what isn't.

Why It Matters

Every Finding Has Two Prices. Timing Decides Which One You Pay.

The unverified warning letter commitments, the half-finished dossier module, the QMS that won't survive its next inspection — none of it changes at closing. What changes is who pays for it.

Found during diligence

It's Leverage.

A finding surfaced inside the diligence window becomes an instrument of the deal — something your counsel and bankers can act on before the money moves.

  • Purchase price adjustment backed by evidence
  • Escrow, holdback, or indemnity sized to the real risk
  • Closing conditions that force remediation onto the seller
  • A clear-eyed walk-away, before the sunk costs pile up
Found after close

It's Your Problem.

The same finding discovered post-close has no negotiating table left. It lands on your integration budget, your timeline, and eventually your board deck.

  • Remediation at 100% your cost, on the agency's clock
  • Approval and launch timelines the deal model never priced
  • Integration stalled behind someone else's backlog
  • Or worse: an inspector finds it before you do

The diligence window is the only time regulatory risk is negotiable. Financial and legal diligence won't catch it: the risk lives in agency correspondence, quality records, and submission files — documents that only read correctly to people who have written and defended them.

M&A deal team negotiating terms over regulatory due diligence findings at a boardroom table
Who We Work For

Three Seats at the Deal Table. We've Sat in All of Them.

Acquirers, sellers, and investors need the same truth at different moments. The engagement is shaped to the seat you're in.

Buy-side diligence team reviewing a target company's regulatory documents together
You're acquiring or in-licensing

Buy-Side Diligence

Full regulatory and quality review of the target — data room, agency correspondence, quality records — reported as deal terms, not observations.

  • Data room review across regulatory, quality, CMC, clinical
  • 483s, warning letters, and CRLs read for what they signal
  • Findings mapped to price, escrow, and disclosure schedules
  • Support through negotiation and closing conditions
Scope the Target
Executive preparing sell-side data room documents ahead of buyer due diligence
You're selling, raising, or partnering

Sell-Side Readiness

Mock diligence on your own asset before the buyer's team arrives — so they find a clean file instead of leverage.

  • Pre-sale diligence run the way a buyer would run it
  • Data room built to answer questions before they're asked
  • Known issues remediated or framed on your terms
  • Management prepped for the buyer's expert sessions
Get Deal-Ready
Regulatory diligence findings presented on screen to an investment committee
You're writing the check

Investor & Board Diligence

Technical diligence for PE, venture, and boards: whether the pathway is viable, the timeline is real, and the risk is priced.

  • Pre-term-sheet triage from public and confidential data
  • Pathway viability and timeline realism, tested against comparables
  • The risks the pitch deck omits, in plain language
  • Findings presented to your investment committee directly
Brief the Committee
What We Examine

Six Workstreams. One Question: What Is This Asset Actually Worth?

Scope flexes to the deal — a single in-licensed program reads differently than a company with three sites — but the review always covers the places value quietly leaks.

Regulatory Status & Agency History

What the agency has actually said, versus what the deal book says the agency said. Correspondence is where diligence findings live.

Registration & filing status by market FDA / EMA meeting minutes CRLs & information requests Post-marketing commitments Pathway & exclusivity assumptions

Quality System & GxP Compliance

The QMS reviewed like the inspection the target hasn't had yet — because after close, that inspection is yours.

Inspection history & open 483s Warning letter remediation status CAPA backlog & aging Deviation & batch record trends Supplier qualification & audits

CMC & Manufacturing

Whether the product can actually be made — at scale, at cost, at the site in the model — after the seller's team walks out.

Process & cleaning validation state Tech transfer readiness CDMO agreements & compliance Stability & specification gaps Single points of failure in supply

Clinical & Safety

The data behind the value story: whether the pivotal evidence holds up, and what the safety database says the label will eventually say.

Pivotal data quality & integrity GCP compliance & monitoring Safety signals & PV system Ongoing study obligations Protocol deviations & amendments

Post-Market Obligations

The standing costs that follow the asset home: commitments, vigilance, and field history the deal model may never have seen.

Complaint & vigilance trends Field actions & recalls Commitments & annual reports Labeling & promotional exposure EU MDR / IVDR transition state

Data Integrity & Documentation

Whether the records can be trusted at all. If the raw data and the reported data disagree, nothing else in the data room matters.

Part 11 / Annex 11 posture Audit trail review Raw data vs. reported data Document control health Legacy system risk

In exclusivity? Every day of the diligence window you're not looking, the risk stays priced at zero.

Talk to an Expert Today
How It Runs

Built for Deal Clocks, Not Consulting Calendars.

Exclusivity windows don't extend because a workstream ran long. The engagement is scoped in days, sequenced around your deal calendar, and reported the way deal teams decide.

Scope to the Thesis

A working session with your deal team: what the valuation assumes, where the thesis is exposed, which workstreams matter for this asset.

Diligence plan within 48 hours

Read the Data Room

Senior reviewers work the documents the way regulators wrote them — flagging what's missing from the index as loudly as what's in it.

Red flags escalated as found, not saved for the report

Test Management

Expert sessions with the target's regulatory and quality leadership, and site walkthroughs where the deal warrants them.

The answers get compared against the documents

Report in Deal Terms

Risk-tiered findings with remediation costs and timelines attached, briefed live to your deal team, counsel, or committee.

What kills, what costs, what can be fixed

Deal team working the data room late in the evening against an exclusivity deadline
On the Deal Clock

Most engagements report inside two to four weeks, sequenced so a red flag reaches your deal team the day it is found, not the day the report is bound.

The Deliverable

A Report Your Deal Team Can Take Into the Negotiation.

Not a literature review. Every finding arrives risk-tiered, costed, and mapped to the deal lever it belongs to.

  • Findings ranked by what they do to the deal

    Deal-critical, price-relevant, or confirmed clean — so your committee reads risk the same way it reads the model, not through fifty pages of observations.

  • Remediation costed and scheduled, not just flagged

    Every red and amber finding carries an estimated cost and timeline to fix — the numbers your model needs and your counsel's disclosure schedule cites.

  • A 100-day plan if you close

    The findings convert directly into a sequenced integration remediation plan — and the team that found the gaps is available to close them.

  • Acquirer executive reading a risk-tiered regulatory due diligence report
Why Teams Pick Us

Senior Operators in the Data Room. Not Analysts on Their First Deal.

Who does the work
The reviewer has sat on both sides of the documents.

The people reading the target's 483s have written responses to their own. The ones judging the dossier have filed and defended dossiers. That's the difference between a finding and a checklist item: knowing which gaps an agency will forgive, which it won't, and what each one costs to close — because they've closed them.

  • Diligence without deal fever

    We hold no success fee and no stake in the deal closing. The report says what the documents say — including "walk away," when that's what they say.

  • Confidential by construction

    Deal-team-only staffing, NDA from the first call, and reporting channels your counsel controls. Most of our diligence work is invisible by design.

  • Fixed scope, fixed price, deal speed

    Diligence runs as a defined project: workstreams, timeline, and price locked before the data room opens, per how we work.

Get Started

Bring Us the Data Room. Or Just the Term Sheet.

Whether diligence opens next week or you're still circling the target, the first conversation is the same: thirty minutes, under NDA, no obligation — and an honest read on what to look at first.

We typically respond within one business day.