Regulatory due diligence for pharma acquisitions — every data-room file read, cited and scored before the bid
Every regulatory file in the data room read and cited, every risk scored before the bid.
See one case, screen by screen ↓The data room opens, the clock to the binding bid starts, and the seller keeps uploading. Project Larch holds 41,870 files; 6,214 of them are regulatory — approval letters, agency correspondence, complete response letters, Form 483s, labeling, PASS reports, eCTD indices. A four-person team in a four-week window reads a sample and leans on the management presentation for the rest.
The management presentation is where the risk hides. It says the ORV-214 complete response letter was “limited to observations at our third-party manufacturer”. The published letter also asks for a thorough QT study — a Class 2 resubmission, and approval a year later than the deck’s plan. A batch of 312 files lands overnight with a safety labeling change inside it, two days before the red-flag report is due. Finding that by hand means reading every letter against the agency’s own words.
Estimated split for one target’s regulatory review, by hand and with the solution.
Specialist agents read every file, build the inventory, check the public record, score, report and plan the transfers; the diligence lead confirms every finding.
Northwind is bidding for Orvelle Pharmaceuticals — Project Larch. It is Day 16 of the data room, the red-flag report is due in two days, and the seller uploaded 312 files overnight. Here is what happens next, screen by screen, in the working solution.
Lena opens the deal cockpit: the deal clock from data room to Day 100 review, a likelihood × impact risk matrix with 9 findings and 1 Critical, and reading coverage at 99.3% — 6,173 of 6,214 regulatory files read and cited. Needs you lists the Critical finding on ORV-214, the overnight batch and a seller answer on Pelandra.
“312 new files uploaded overnight by the seller · Batch 14 · folders 4.3 Correspondence and 4.5 Labeling · not read yet”
The Data Room Reader logs the 312 files and classifies them: 41 regulatory — 23 agency correspondence, 18 labeling — and 271 finance and legal. The Inventory Extractor pulls 64 facts with page citations and one new agency clock, response due Oct 21. The Public Record Checker notes the safety labeling change is not yet public. The Risk Scorer raises one new finding.
“R-06 · Major. FDA asks for a liver-injury warning on Tavirel; the seller’s forecast assumes no label change.”
Ten findings now: 1 Critical, 4 Major, 5 Minor, and 2 questions with the seller. Each carries its area — approvals, commitments, inspections, labeling, archive, licences, promotion — its likelihood × impact score, its effect on the deal and its status. R-06 sits at 16: “Tavirel forecast −4% to −7% from 2027”.
R-01 puts the two side by side. The management presentation, slide 14, against the complete response letter for NDA 900611, page 3, from the public record. Below them, the seller’s plan and what the record supports: a Class 1 resubmission and approval mid-2027, against a thorough QT study, a Class 2 resubmission with a six-month review, and approval mid-2028 at the earliest.
Seller: “CRL received February 2026, limited to observations at our third-party manufacturer.” Record: “Conduct a thorough QT study, or an alternative assessment agreed with the Agency, that covers these exposures.”
The why: the letter lists two deficiencies and the deck names one; at the Type A meeting FDA did not accept concentration-QTc modelling; a resubmission with new clinical data is Class 2; Meridale Site 4 is classified Official Action Indicated. The trace shows how each agent got there, and a seller question is drafted from the gaps — the unredacted CRL, the thorough QT protocol, the 483 response, the basis for Class 1.
Thorough QT duration is a planning estimate; the six-month review goal is from the letter.
Lena can ask the seller, downgrade with a reason kept on the audit trail, or confirm. She confirms. Because R-01 scores at or above the Critical threshold, it does not go to the deal team yet: it goes to Dana Okafor, head of global regulatory strategy, for sign-off.
Dana signs with an electronic signature: signer, meaning — “Approved — release to the deal team” — and password. The audit trail records her name, the time and the meaning. The finding moves to In the report, and the proposed protection goes with it: a contingent value right tied to ORV-214 approval and a specific indemnity for Meridale remediation costs.
“Signed — R-01 is with the deal team, inside 24 hours of being raised”
The Report Writer drafts six sections from the confirmed findings — summary, Critical findings, Major findings, registrations and commitments, recommended protections, integration — with a citation on every sentence. Dana signs it for the deal committee, meaning: approved for the deal committee.
The inventory becomes the integration plan. The Integration Planner picks each market’s route — 21 CFR 314.72 letters in the US, Regulation (EC) 2141/96 in the EU, national transfers in the UK, Canada, Switzerland and Australia; Japan stays with the licensee — and schedules 13 registrations and 1,842 eCTD sequences from the Dec 1 close. Sam approves; tasks are created for 11 workstreams.
Open findings travel with the plan: the thorough QT study under Northwind (R-01) and the Japan licence assignment consent (R-08).
The same data room, seen by the five people who carry it from first read to the last transfer — what their weeks looked like, and what they look like now.
Specialist agents read every file, build the inventory, check the public record, score, report and plan the transfers; the diligence lead confirms every finding.
Reads every file the seller uploads, classifies it — approval, agency letter, complete response, inspection, labeling, archive, contract — and links it to a product.
Builds the inventory: every registration, commitment (PMR, PMC, PASS, conditions), open agency question with its clock, and inspection — each with a page citation.
Pulls the public side — published complete response letters, EPARs, inspection classifications, warning letters — and compares it with what the data room says.
Raises findings with likelihood × impact, a months-and-value effect, a question for the seller and a proposed purchase-agreement protection — every reason cited.
Drafts the red-flag report section by section from confirmed findings, with a citation on every sentence, and exports it to PDF and Word.
At signing, turns the inventory into the transfer and archive plan: the legal route, steps and clock for each market, scheduled from the close date.
Confirms each finding. The agents propose; a named person decides.
The deal team can ask about any file in the data room, a finding, a commitment or the transfer plan — or tell it to change a rule. Every answer is cited.
What did the seller leave out about ORV-214?
The seller’s deck says the complete response letter was limited to manufacturing. The published letter lists a second deficiency: FDA wants a thorough QT study, and in the Type A meeting FDA did not accept modelling instead. A resubmission with new clinical data is Class 2, a six-month review. Approval moves from mid-2027 to mid-2028 at the earliest.
Which commitments are overdue or at risk?
The Pelandra PREA assessment was due Dec 31, 2025 and is overdue. The ORV-214 thorough QT study, needed before resubmission, has not started. The Tavirel EU registry, due Mar 2028, is 37% enrolled. Three others, due 2027, are on track. FDA has already written to Orvelle about Pelandra, and the letter will be made public.
How long will the registration transfers take?
US, 4 applications by 21 CFR 314.72 letters: Day 14–30. EU, 2 authorisations under Regulation (EC) 2141/96: Day 65, packs Day 118. UK, Canada, Switzerland and Australia by national transfers: Day 70–110. Japan stays with the licensee. The last transfer lands on Day 118 after the Dec 1 close.
Add a rule: treat any agency request for a new clinical study as Critical
Done. From now on, when a complete response letter, meeting minutes or scientific advice asks for a new clinical study, the Risk Scorer sets impact 5 and the finding goes to Dana Okafor for sign-off. The rule is on in Settings and recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
Thresholds, signers and what counts as a finding are settings for each deal.
| Setting | Default | Choose from |
|---|---|---|
| Critical from | Score 20 | − / + in steps of 1, from one above Major up to 25 |
| Major from | Score 9 | − / + in steps of 1, from 2 up to one below Critical |
| Who signs Critical findings | Dana Okafor | Dana Okafor · Dr. Maya Chen |
| Who signs the red-flag report | Dana Okafor | Dana Okafor · Omar Haddad |
| Who approves the integration plan | Sam Patel | Sam Patel · Dana Okafor |
| Compare seller statements with the agency’s own words | On | On · Off |
| Flag commitments past their due date | On | On · Off |
| Read new seller uploads within 2 hours | On | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample deal data · “target” = the design goal, measured in the live solution · “estimated” = our estimate of where a review’s days go · the ~30% sampled-review share is an estimate for a four-person team in a four-week window · transfer routes: 21 CFR 314.72 and Regulation (EC) 2141/96. People, companies and products named on this page are fictional — characters and sample data in the working solution.
It is the review of a target’s regulatory position before the bid: which approvals it holds and where, what commitments it owes, what agencies have asked or found, and what that means for value and timing. Regulatory Due Diligence reads every regulatory file in the data room, builds the registration and commitment inventory, scores the risks and drafts the red-flag report, with a citation on every sentence.
The Public Record Checker pulls published complete response letters, EPARs, inspection classifications and warning letters for the target’s products and sites, and the Risk Scorer compares them with the seller’s documents. Where a management presentation and the agency’s own words disagree, the finding shows both side by side and the public record wins.
Yes. A risk rule, on by default, reads nightly and ad-hoc seller batches within 2 hours. In the working solution an overnight batch of 312 files was read, classified and scored in 5.8 seconds, raising one new Major finding.
Each finding gets a likelihood and an impact from 1 to 5; severity is the product. By default 20 and above is Critical and goes for sign-off and to the deal team within 24 hours, 9 and above is Major for the weekly deal meeting, and the rest are Minor. Both thresholds are settings.
Yes. The agents raise and score; the diligence lead confirms, downgrades with a reason or asks the seller. A Critical finding is signed by a named person with an electronic signature before it reaches the deal team, and the red-flag report is signed before it reaches the deal committee.
Each deal runs in a restricted workspace with named members. Every view and download is logged, exports are watermarked with the reader’s name, valuation effects are visible to the clean team only, and the agents never send anything about the deal outside.
Yes. At signing the Integration Planner turns the inventory into a plan per market — 21 CFR 314.72 letters in the US, Regulation (EC) 2141/96 in the EU, national transfers elsewhere — scheduled from the close date, with the eCTD archive migration and a Day 1 checklist. The integration lead approves it before any task starts.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your risk rules, report template and a past deal’s regulatory files — and it goes live once every quality gate has passed. We will walk you through it on your own data first.
Every agency change reaches the right team within hours, translated and cited.
1-min filmSubmission SummariesModule 2 summaries drafted in weeks, every statement cited to its source page.
1-min filmAgency ResponsesEvery agency question gets a cited first draft within hours, consistent with every past answer.
1-min filmWe’ll run Regulatory Due Diligence on a sample of a past deal’s regulatory files.