Regulatory & Quality Diligence
Due Diligence
& Gap
Assessments
Know the regulatory price before you sign
Know the regulatory price before you sign
The most expensive findings in life sciences are the ones discovered after signing: the warning letter history nobody surfaced, the dossier module that was never finished, the quality system built for a product that no longer exists. We read a target the way a regulator would, then translate what we find into the only language a deal team can act on: cost, timeline, and leverage. Whether you are buying, raising, or being bought, it is the same discipline aimed at a different side of the table.
The finding a data room hides is the one that resets the price after close.
Diligence is not one report. The question changes with who is asking, and a review built for the wrong audience answers questions nobody in the room actually has.
What am I actually acquiring?
We read the data room the way an FDA or notified body reviewer would, surface the risks the seller normalized, and map each one to what it will cost to fix and how long it will take.
Does the regulatory path hold?
An investment committee needs a verdict, not a literature review. We assess what actually moves the thesis and deliver it on the deal's clock, in terms a board can act on.
What will a buyer find?
Every gap a buyer discovers costs more than the fix would have. We run the diligence on you first, so you close the findings, or price them, before someone else uses them against you.
Buy-side asks what is hidden. Sell-side asks what a buyer will find. The review is built for the seat you are in.
A gap assessment is only useful if it measures your reality against what the authority requires today, not against ambition or the standard that passed five years ago. We run two, because regulatory risk and quality risk fail in different ways.
Two lenses on one asset: what the reviewer expects now, and what the investigator will find.
Your dossiers, submissions, and commitments measured against what the reviewing authority expects now. Where is the module thin, the commitment unmet, the label claim unsupported? This is the gap that stalls an approval or a transfer.
Your quality system read the way an investigator reads it: the CAPA that never closed, the validation that was never signed, the data-integrity control that exists on paper only. This is the gap a pre-approval inspection finds, on its schedule instead of yours.
Eighty findings in a spreadsheet paralyze a deal team. The same eighty, placed by severity and by effort to remediate, become a plan: what to fix before close, what to price in, and what can safely wait.
Findings ranked by regulatory risk and by effort, with owners, a sequence, and a number attached.
Material risk you can close cheaply. There is no reason to carry it into the deal, so remediate it now.
Real exposure you cannot fix before signing. It becomes a price chip, an escrow, or a condition, quantified so the negotiation is honest.
Minor gaps with easy fixes. They belong in the first hundred-day integration plan, not the negotiation.
Low-impact items that are expensive to chase. Log them, own them, and revisit only if the risk profile changes.
Full diligence on every candidate burns budget and attention. We run rapid triage on in-licensing and acquisition targets from public information, so only the real prospects reach a full review and the obvious walk-aways die cheaply.
Closing transfers the equity, not the marketing authorizations, establishment registrations, or quality obligations. We run the regulatory and quality integration that actually makes the asset operable, so the value is realized instead of stranded.
Credible diligence comes from having sat on both sides: from building the dossiers and quality systems now being examined, and from examining them for regulators and acquirers. Your leads are senior regulatory and quality practitioners who translate findings into deal terms without losing the technical truth underneath.
A verdict when the committee needs it, not a report that lands after the window has closed.
We have built what we now assess, and assessed it for buyers, so we know where the bodies are usually buried.
Every finding carries a severity, an effort, and a number, because a list without a price is not a decision.
Diligence lives or dies on discretion. Engagements are handled accordingly, on both sides of a transaction.
A finding is only useful if someone can close it. These are the services a diligence engagement most often hands off to.
The transaction-focused quality and regulatory review for buyers and sellers moving on a defined deal.
Explore M&A →The remediation muscle behind a quality finding: closing the CAPA, signing the validation, fixing the system.
Explore GxP →The strategy that closes a regulatory gap: the meeting, the submission, the commitment brought current.
Explore Consulting →Tell us what's ahead: a data room opening, a term sheet under negotiation, an inspection window, or a file you suspect has gaps. We'll match you with a senior diligence lead and respond within one business day. All inquiries are strictly confidential.
