Due Diligence
& Gap
Assessments

Leaders in Regulatory Risk Assessment

Why Diligence Matters

Every Deal Prices In Regulatory Risk. Know the 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 QMS that cannot survive its next inspection. We run regulatory and quality due diligence for acquirers, licensees, and investors, and gap assessments for companies that want to find their own weaknesses before a buyer, an agency, or a notified body does. Senior operators do the review, and the report tells you what each finding means in deal terms: what kills, what costs, and what can be fixed on a known timeline.

Data room opens soon? Diligence windows don't extend because the documents arrived late.

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Capabilities

From First Look to Closed Findings.

We support both sides of the risk question: diligence when you are evaluating someone else's asset, and gap assessments when the asset under scrutiny is your own.

M&A & Licensing Diligence

Buy-side regulatory and quality review of targets and in-licensing candidates: data room to red-flag report, in deal time.
Investor & Board Diligence

Technical diligence for venture, private equity, and boards: pathway viability, timeline realism, and the risks the pitch deck omits.
Sell-Side & DD Readiness

Mock diligence and data room preparation for companies raising, partnering, or selling, so buyers find a clean file instead of leverage.
Regulatory Gap Assessments

Dossier, submission, and technical documentation gap analyses against FDA, EMA, and EU MDR/IVDR requirements as they stand today.
Quality & GxP Gap Assessments

QMS assessments against 21 CFR, ISO 13485, and GMP expectations, run like the inspection you haven't had yet.
Remediation Roadmaps

Findings turned into sequenced, resourced, risk-ranked plans, with senior leadership available to run the closure.
M&A & Licensing Diligence

The Red Flags Are in the Data Room. Someone Has to Know Where to Look.

A data room rewards the reviewer who knows which documents matter: the FDA meeting minutes that quietly contradict the development plan, the 483 whose corrective actions were never verified, the post-marketing commitment nobody budgeted for. Our diligence teams read agency correspondence, submissions, and quality records the way regulators wrote them, then report findings in the language your deal team actually needs: what kills the deal, what changes the price, and what belongs in the disclosure schedule.

What We Review

  • Full data room review across regulatory, quality, clinical, and CMC
  • Agency correspondence analysis: meeting minutes, CRLs, 483s, warning letters
  • Registration and filing status verification across target markets
  • Post-marketing commitments, conditions, and open obligations
  • Manufacturing and supplier compliance history
  • Red-flag report with findings ranked in business terms
  • Support through negotiation, disclosure, and closing conditions
Investor & Board Diligence

Your Investment Committee Needs an Answer, Not a Literature Review.

Investment decisions run on a different clock than regulatory ones, and most technical diligence reports answer questions nobody asked. We assess what the committee actually decides on: whether the claimed pathway is viable, whether the timeline survives contact with the agency, what the next value inflection really depends on, and which risks are priced versus discovered. Findings arrive as a decision document, presented directly to the committee or board when you want us in the room.

What We Assess

  • Pre-term-sheet triage from public and confidential data
  • Regulatory pathway viability: 505(b)(2), accelerated, orphan, De Novo, PMA
  • Agency interaction history and what it signals about approval risk
  • Timeline and budget realism against comparable programs
  • Management team regulatory and quality capability
  • Competitive and standard-of-care positioning
  • Written risk report plus investment committee presentation
Sell-Side & DD Readiness

Every Gap a Buyer Finds Costs More Than the Fix Would Have.

In a sale, a financing, or a partnering process, an unexplained gap becomes negotiating leverage against you: a price chip, an escrow, a walked deal. We run the diligence on your own company before anyone else does, remediate what can be fixed inside the process timeline, and prepare honest, pre-framed answers for what cannot. Companies that have done this work walk into the data room knowing what will be found, because they found it first.

How We Prepare You

  • Internal mock diligence run to a buyer's standard
  • Data room architecture and document curation
  • Regulatory history narrative: filings, meetings, and commitments in one story
  • Fast remediation of findings fixable before the process opens
  • Disclosure strategy for findings that cannot be fixed in time
  • Management preparation for buyer Q&A sessions
  • Support through confirmatory diligence to close

Term sheet on the table? Get a red-flag read before exclusivity locks you in.

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Regulatory Gap Assessments

Measure the Dossier Against the Requirement, Not the Ambition.

A gap assessment is only useful if it compares your documentation to what the reviewing authority requires today, not to what passed five years ago. We assess dossiers, technical documentation, and submission packages against current FDA, EMA, and EU MDR/IVDR expectations, module by module and annex by annex. The deliverable is a gap register that states what is missing, what is outdated, what an assessor will challenge, and what closing each gap takes in time and money.

What We Assess

  • CTD/eCTD dossier gap analysis across Modules 1 through 5
  • IND, NDA, and BLA submission readiness reviews
  • 510(k), De Novo, and PMA readiness assessments
  • EU MDR/IVDR technical documentation gaps per Annexes II and III
  • Currency checks against new guidance, MDCG documents, and standards
  • Labeling, IFU, and promotional material compliance review
  • Gap register with effort, cost, and sequencing estimates
Quality & GxP Gap Assessments

An Inspection Finds Your Gaps Eventually. An Assessment Finds Them First.

The difference between a gap assessment and an inspection is who controls the timeline afterward. We assess quality systems the way investigators do: following the data, testing whether procedures match practice, and pulling the thread on the deviations everyone learned to live with. You get the 483 you didn't have to receive, with time to fix it quietly instead of under a response deadline.

What We Examine

  • QMS gap assessments against 21 CFR Parts 210/211, 820, and ISO 13485
  • Mock FDA inspections and notified body audit simulations
  • Data integrity and 21 CFR Part 11 assessments
  • CAPA system effectiveness and deviation trend review
  • Supplier and CMO quality oversight evaluation
  • Inspection history analysis: 483s, EIRs, and warning letter context
  • Pre-approval inspection (PAI) readiness for pending submissions
Remediation Roadmaps

A Findings List Isn't a Plan. Sequence It, Resource It, Close It.

Most assessments die as spreadsheets: eighty findings, no owners, no order, no budget. We turn findings into a remediation program ranked by regulatory risk, sequenced by dependency, and sized against the deadlines that actually bind you, whether that is a certificate expiry, a PAI window, or an integration plan. When you need more than a roadmap, our fractional leaders step in and run the closure themselves.

How We Close Gaps

  • Risk-ranked remediation roadmaps with owners and dependencies
  • Effort and cost estimation for each workstream
  • CAPA program design and effectiveness checks
  • Fractional regulatory and quality leadership to execute
  • Post-acquisition integration: QMS harmonization and registration transfers
  • Progress governance with board and investor reporting
  • Independent re-assessment and closure verification
Adjacent Capabilities

Before the Deal, and After It.

Two engagements bracket the diligence itself: screening assets before you commit diligence budget, and transferring what you bought once the ink is dry.

Pre-Deal Asset Screening

Kill the Bad Deals Before They Cost Diligence Money.

Full diligence on every candidate burns budget and attention. We run rapid triage on in-licensing candidates and acquisition targets using public information: approval histories, inspection databases, trial registries, and agency precedent for the claimed pathway. Most screens finish in days and end with a clear answer: advance to full diligence, renegotiate the premise, or walk away now.

Included Capabilities

  • Rapid red-flag screens from public and published sources
  • FDA and EMA precedent analysis for the claimed pathway
  • Inspection and enforcement history review (483s, warning letters, import alerts)
  • Clinical trial registry and results consistency checks
  • Target product profile validation against regulatory precedent
  • Portfolio prioritization across multiple candidates
Post-Close Transfers & Integration

The Asset Isn't Yours Until the Registrations Are.

Closing the deal transfers the equity; it does not transfer the marketing authorizations, the establishment registrations, or the quality system obligations. We plan and execute the regulatory mechanics of ownership change across markets, keep products supplied through the transition, and merge two quality systems into one that survives its next inspection.

Included Capabilities

  • Marketing authorization and 510(k)/PMA ownership transfers
  • Establishment registration and listing updates
  • Change-of-ownership submissions across global markets
  • Technical transfer regulatory support for site moves
  • QMS integration and procedure harmonization
  • Day-one and 100-day regulatory integration plans
Who You're Working With

Assessed by People Who Have Run the Functions They're Assessing.

A checklist reviewer confirms documents exist. An operator knows whether they would survive contact with an inspector, a reviewer, or a buyer's counsel. Our diligence teams are built from people who have owned these functions: heads of regulatory affairs, heads of quality, and former agency and notified body staff.

Operators, Not Auditors

Former VPs of regulatory and quality who have lived with the consequences of these findings. They distinguish real risk from paperwork noise, because they have owned both.

Deal-Cycle Fluency

Teams that work inside exclusivity windows and investment committee calendars, deliver interim red flags as they surface, and keep the report aligned to the decision it serves.

Inspection-Side Experience

Consultants who have conducted inspections and audits for agencies and notified bodies. A gap assessment is only as good as the inspector mindset behind it.

Modality and Market Breadth

Small molecule, biologics, cell & gene therapy, devices, diagnostics, and combination products, assessed against FDA, EMA, MHRA, and notified body expectations.

Work With Us

The Deal Clock Is Already Running.

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.

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Insights & News

Thought Leadership on Risk and Readiness.

Our team's perspectives on diligence, gap assessment, and what actually surfaces in data rooms and inspections: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

The Five Findings That Kill Life Science Deals

What actually stops transactions, and what merely reprices them.

Coming Soon

Reading a 483 Like a Buyer

Why the response matters more than the finding, and how to weigh both in a deal.

Coming Soon

Gap Assessments That Survive the Re-Audit

Why most remediation programs stall at sixty percent, and how to structure one that closes.